SUGAR CORAL TINTED LIP TREATMENT SUNSCREEN SPF 15- octinoxate paste

SUGAR CORAL TINTED LIP TREATMENT SUNSCREEN SPF 15 by

Drug Labeling and Warnings

SUGAR CORAL TINTED LIP TREATMENT SUNSCREEN SPF 15 by is a Otc medication manufactured, distributed, or labeled by Fresh, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, Passiflora Incarnata Seed Oil, Sucrose Tetrastearate Triacetate, Ribes Nigrum (Black Currant) Seed Oil, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Polyglyceryl-3 Polyricinoleate, Ammonium Glycyrrhizate, Vanillin, BHT, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol, (May contain CI 15850 (Red 6 Lake, 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) <12341Z>

SUGAR CORAL TINTED LIP TREATMENT SUNSCREEN SPF 15– 4.3g (

42406-052-04)

INGREDIENTS AND APPEARANCE

SUGAR CORAL TINTED LIP TREATMENT SUNSCREEN SPF 15 
octinoxate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-052
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-052-04	1 in 1 BOX	04/01/2019
1		4.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - Fresh, Inc. (021403729)