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NDC 70186-0600-03 LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 .158; .525; .263; .525 g/5mL; g/5mL; g/5mL; g/5mL Details

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 .158; .525; .263; .525 g/5mL; g/5mL; g/5mL; g/5mL

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Charlotte Tilbury Beauty Ltd.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	70186-0600
Product ID	70186-600_0c272e95-3147-462b-86c5-a2412725bfd3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate and Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.158; .525; .263; .525
Active Ingredient Units	g/5mL; g/5mL; g/5mL; g/5mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Charlotte Tilbury Beauty Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70186-0600-03 (70186060003)

Pricing Information	N/A
NDC Package Code	70186-600-03
Billing NDC	70186060003
Package	1 BOTTLE, PUMP in 1 CARTON (70186-600-03) / 50 mL in 1 BOTTLE, PUMP
Marketing Start Date	2020-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3837da32-998a-4b98-9695-4c986f25eaf1 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients Purpose

Avobenzone: 3% Sunscreen

Homosalate: 10% Sunscreen

Octisalate: 5% Sunscreen

Octocrylene: 10% Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

SPL UNCLASSIFIED SECTION

Do not use on damaged or broken skin

SPL UNCLASSIFIED SECTION

When using this product keep out of eyes. Rinse with water

to remove.

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if rash occurs

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If product is swallowed, get medical help, or contact a Poison Control Center right away.

Directions

• apply liberally and evenly 15 minutes before sun exposure

• children under 6 months of age: ask a doctor

• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m. – 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

• use a water-resistant sunscreen if swimming or sweating

• reapply:

• at least every 2 hours

• immediately after towel drying

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Coconut Alkanes, Glycerin, Silica, Crambe Abyssinica Seed Oil, Cetyl Alcohol, Glyceryl Stearate, Caprylyl Methicone, Potassium Cetyl Phosphate, PEG-75 Stearate, Dimethyl Isosorbide, Polysorbate 20, Phenoxyethanol, Hydroxyacetophenone, Marrubium Vulgare Extract, Ceteth-20, Steareth-20, Coco-Caprylate/Caprate, Xanthan Gum, Carbomer, Disodium EDTA, Rosa Damascena Extract, Ethylhexylglycerin, Sodium Hydroxide, Beta-Carotene, Tocopherol, Xanthophylls, Michelia Alba Leaf Oil, Citric Acid, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solanum Tuberosum Pulp Extract, Acetyl Tetrapeptide-11, Acetyl Tetrapeptide-9, Linalool, Citronellol, Geraniol.

OTHER INFORMATION

• protect the product in this container from excessive heat and direct sun

Principal Display Panel - 5 mL 0.16 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

5 mL e 0.16 FL. OZ.

Principal Display Panel - 15 mL 0.48 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

15 mL e 0.48 FL. OZ.

Principal Display Panel - 50 mL 1.6 FL. OZ.

LIGHTWEIGHT,

MIRACLE MOISTURIZER

SUNSCREEN BROAD SPECTRUM SPF 20

50 mL e 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20

avobenzone, homosalate, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70186-600
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.525 g in 5 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.525 g in 5 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.263 g in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.158 g in 5 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
COCONUT ALKANES (UNII: 1E5KJY107T)
GLYCERIN (UNII: PDC6A3C0OX)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PEG-75 STEARATE (UNII: OT38R0N74H)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HOREHOUND (UNII: K08036XEJV)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BETA CAROTENE (UNII: 01YAE03M7J)
TOCOPHEROL (UNII: R0ZB2556P8)
LUTEIN (UNII: X72A60C9MT)
MICHELIA ALBA LEAF OIL (UNII: 002RK9L1FN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
POTATO PULP (UNII: 844I2DX0IS)
ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)
ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
GERANIOL (UNII: L837108USY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70186-600-01	1 in 1 CARTON	06/01/2020
1		5 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC:70186-600-02	1 in 1 CARTON	06/01/2020
2		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC:70186-600-03	1 in 1 CARTON	06/01/2020
3		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2020

Labeler - Charlotte Tilbury Beauty Ltd. (218353520)

Revised: 4/2020

Document Id: 0c272e95-3147-462b-86c5-a2412725bfd3

Set id: 3837da32-998a-4b98-9695-4c986f25eaf1

Version: 1

Effective Time: 20200401

Search by Drug Name or NDC

NDC 70186-0600-03 LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 .158; .525; .263; .525 g/5mL; g/5mL; g/5mL; g/5mL Details

LIGHTWEIGHT MIRACLE MOISTURISER SUNSCREEN BROAD SPECTRUM SPF 20 .158; .525; .263; .525 g/5mL; g/5mL; g/5mL; g/5mL

Product Information

Package

Package Images

NDC 70186-0600-03 (70186060003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3837da32-998a-4b98-9695-4c986f25eaf1 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Inactive ingredients

OTHER INFORMATION

Principal Display Panel - 5 mL 0.16 FL. OZ.

Principal Display Panel - 15 mL 0.48 FL. OZ.

Principal Display Panel - 50 mL 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

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