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NDC 42406-0030-04 SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15 67.4 mg/g Details

SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15 67.4 mg/g

SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15 is a TOPICAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Fresh Inc. The primary component is OCTINOXATE.

Product Information

NDC	42406-0030
Product ID	42406-030_d3647857-ae80-0660-e053-2995a90ab464
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	SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15
Proprietary Name Suffix	n/a
Non-Proprietary Name	OCTINOXATE
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	67.4
Active Ingredient Units	mg/g
Substance Name	OCTINOXATE
Labeler Name	Fresh Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 42406-0030-04 (42406003004)

Pricing Information	N/A
NDC Package Code	42406-030-04
Billing NDC	42406003004
Package	1 BOX in 1 CARTON (42406-030-04) / 4.3 g in 1 BOX
Marketing Start Date	2017-08-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1bbf1af8-a42c-44e3-976b-9c81e8eafb66 Details

Drug Facts

Active Ingredients

Octinoxate 6.74%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• Apply liberally 15 minutes before sun exposure

• Use a water resistant sunscreen if swimming or sweating

• Reapply at least every 2 hours

• Children under 6 months: Ask a doctor

Other Information

Protect this product in container from excessive heat and direct sun

Questions or Comments?

Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

Inactive Ingredients

Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Sucrose Tetrastearate Triacetate, Passiflora Incarnata Seed Oil, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Synthetic Fluorphlogopite, Polyglyceryl- 3 Polyricinoleate, Ammonium Glycyrrhizate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol, [May Contain: CI 15850 (Red 6, Red 7, Red 7 Lake), CI 15985 (Yellow 6, Yellow 6 Lake), CI 19140 (Yellow 5, Yellow 5 Lake), CI 42090 (Blue 1 Lake), CI 45410 (Red 27, Red 27 Lake, Red 28 Lake), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide)] <12299/Z>

Package Labeling:

INGREDIENTS AND APPEARANCE

SUGAR SPICE LIP TREATMENT SUNSCREEN SPF 15

octinoxate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42406-030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
VANILLIN (UNII: CHI530446X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYL GALLATE (UNII: 8D4SNN7V92)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42406-030-04	1 in 1 CARTON	08/05/2017	01/12/2024
1		4.3 g in 1 BOX; 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	08/05/2017	01/12/2024

Labeler - Fresh Inc (021403729)

Revised: 12/2021

Document Id: d3647857-ae80-0660-e053-2995a90ab464

Set id: 1bbf1af8-a42c-44e3-976b-9c81e8eafb66

Version: 4

Effective Time: 20211217