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NDC 42406-0050-02 SUGAR LIP TREATMENT SUNSCREEN SPF 15 67.4 mg/g Details

SUGAR LIP TREATMENT SUNSCREEN SPF 15 67.4 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 OCTINOXATE.

Product Information

NDC	42406-0050
Product ID	42406-050_d365d56f-f499-f8c3-e053-2995a90ae3cb
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	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 42406-0050-02 (42406005002)

Pricing Information	N/A
NDC Package Code	42406-050-02
Billing NDC	42406005002
Package	1 TUBE in 1 BOX (42406-050-02) / 2.2 g in 1 TUBE
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06555160-9064-471e-bc87-55d0930df554 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

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, Linalool, Benzyl Alcohol <12958/Z>

SUGAR LIP TREATMENT SUNSCREEN SPF 15– 2.2g (42406-050-02)

SUGAR LIP TREATMENT SUNSCREEN SPF 15– 4.3g (42406-050-04)

INGREDIENTS AND APPEARANCE

SUGAR LIP TREATMENT SUNSCREEN SPF 15

octinoxate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42406-050
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
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)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL ALCOHOL (UNII: LKG8494WBH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42406-050-02	1 in 1 BOX	04/01/2019	01/12/2024
1		2.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:42406-050-04	1 in 1 BOX	04/01/2019	01/12/2024
2		4.3 g in 1 TUBE; 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	04/01/2019	01/12/2024

Labeler - Fresh, Inc. (021403729)

Revised: 12/2021

Document Id: d365d56f-f499-f8c3-e053-2995a90ae3cb

Set id: 06555160-9064-471e-bc87-55d0930df554

Version: 3

Effective Time: 20211218