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NDC 42406-0032-04 SUGAR LIP TREATMENT SUNSCREEN SPF 15 20; 74.9 mg/g; mg/g Details

SUGAR LIP TREATMENT SUNSCREEN SPF 15 20; 74.9 mg/g; mg/g

SUGAR 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 AVOBENZONE; OCTINOXATE.

Product Information

NDC	42406-0032
Product ID	42406-032_d364c21b-b064-2f1e-e053-2995a90a398d
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 LIP TREATMENT SUNSCREEN SPF 15
Proprietary Name Suffix	n/a
Non-Proprietary Name	AVOBENZONE, OCTINOXATE
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	TOPICAL
Active Ingredient Strength	20; 74.9
Active Ingredient Units	mg/g; mg/g
Substance Name	AVOBENZONE; 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 42406-0032-04 (42406003204)

Pricing Information	N/A
NDC Package Code	42406-032-04
Billing NDC	42406003204
Package	1 BOX in 1 CARTON (42406-032-04) / 4.3 g in 1 BOX
Marketing Start Date	2017-11-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e51c83cd-249f-49da-a7f8-16b9bec26c2c Details

Drug Facts

Active Ingredients

Avobenzone 2.00%

Octinoxate 7.49%

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

Ricinus Communis (Castor) Seed Oil, Cera Alba (Beeswax), Hydrogenated Olive Oil Decyl Esters, Simmondsia Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Citrus Limon (Lemon) Peel Oil, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Vanillin, BHT, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol <10705/Z>

Package Labeling:

INGREDIENTS AND APPEARANCE

SUGAR LIP TREATMENT SUNSCREEN SPF 15

avobenzone, octinoxate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42406-032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
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)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
LEMON OIL (UNII: I9GRO824LL)
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)
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:42406-032-04	1 in 1 CARTON	11/06/2017	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	11/06/2017	01/12/2024

Labeler - Fresh Inc (021403729)

Revised: 12/2021

Document Id: d364c21b-b064-2f1e-e053-2995a90a398d

Set id: e51c83cd-249f-49da-a7f8-16b9bec26c2c

Version: 4

Effective Time: 20211217