BRONZ REPAIR SEA AND TROPICS FACE SPF 25- octinoxate, avobenzone cream

BRONZ REPAIR SEA AND TROPICS FACE SPF 25 by

Drug Labeling and Warnings

BRONZ REPAIR SEA AND TROPICS FACE SPF 25 by is a Otc medication manufactured, distributed, or labeled by Naos USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octinoxate 6%

Avobenzone 2.6%

Purpose

Sunscreen

Uses

• Help prevent sunburn.

Warnings

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 reach of children.

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

Directions

• Apply liberally, and spread evenly by hand 15 min before sun exposure. 
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating
• 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-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.

Other information

• Keep the product between 15-30ºC.
• Protect the product in this container from excessive heat and direct sun.

Question or comments?

Call to 1 877 443 3762

Inactive Ingredients

Water, Dicaprylyl Carbonate, Ethylhexyl Methoxycrylene, Glyceryl Stearate, Glycerin, Dipropylene Glycol, Peg-100 Stearate, Cyclopentasiloxane, Cetyl Alcohol, Methyl Methacrylate Crosspolymer, Cera Alba/Beeswax / Cire D'abeille, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-cresol, Oryzanol Creatine, Fragrance (Parfum), Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Oryza Sativa (Rice) Bran Oil, Pentylene Glycol, Pongamol, Butylene Glycol, Trilinolein, Caprylyl Glycol, Xanthan Gum, 1,2-hexanediol, Acetyl Tyrosine, Aspartic Acid, Cerium Oxide, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil, Polyethylene, Disodium Edta, Hydrogenated Castor Oil, Sodium Dextran Sulfate, Polysilicone-11, Sodium Hydroxide, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Potassium Sorbate, Triolein, Tripalmitin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Hydrolyzed Wheat Protein, Oleic Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Medicago Sativa (Alfalfa) Extract, Trilinolenin, Phenoxyethanol, Propylene Glycol, Alcohol, Carbomer, Sodium Lactate, Tristearin, Tris(Tetramethylhydroxypiperidinol) Citrate, Polysorbate 20, Copper Gluconate, Bht, Asiaticoside, Artemia Extract, Madecassic Acid, Carnosine, Tocopherol, Asiatic Acid, Triarachidin, Disodium Adenosine Triphosphate, Laminaria Digitata Extract, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Acetyl Hexapeptide-1, Dextran, Red 33 (CI 17200), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Geraniol, Citronellol, Isoeugenol, Coumarin, Citral..

Package Labeling:

INGREDIENTS AND APPEARANCE

BRONZ REPAIR SEA AND TROPICS FACE SPF 25 
octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PEG-100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
WHITE WAX (UNII: 7G1J5DA97F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
ENOXOLONE (UNII: P540XA09DR)
MANNITOL (UNII: 3OWL53L36A)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
WHITE RICE (UNII: A195V20H7A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PONGAMOL (UNII: 8Y19QCY6I4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRILINOLEIN (UNII: V5LJ52OGS7)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
N-ACETYLTYROSINE (UNII: DA8G610ZO5)
ASPARTIC ACID (UNII: 30KYC7MIAI)
CERIC OXIDE (UNII: 619G5K328Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
OLEOYL TYROSINE (UNII: 131P1BQX1U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
TRIPALMITIN (UNII: D133ZRF50U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
OLEIC ACID (UNII: 2UMI9U37CP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
ALFALFA (UNII: DJO934BRBD)
TRILINOLENIN (UNII: OI7S0A9873)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
SODIUM LACTATE (UNII: TU7HW0W0QT)
TRISTEARIN (UNII: P6OCJ2551R)
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COPPER GLUCONATE (UNII: RV823G6G67)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ASIATICOSIDE (UNII: PKO39VY215)
MADECASSIC ACID (UNII: M7O1N24J82)
CARNOSINE (UNII: 8HO6PVN24W)
TOCOPHEROL (UNII: R0ZB2556P8)
ASIATIC ACID (UNII: 9PA5A687X5)
TRIARACHIDIN (UNII: 48RPR95FW8)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CYCLOHEXYL CINNAMATE (UNII: 2955WP594O)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL BENZOATE (UNII: N863NB338G)
GERANIOL (UNII: L837108USY)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOEUGENOL (UNII: 5M0MWY797U)
COUMARIN (UNII: A4VZ22K1WT)
CITRAL (UNII: T7EU0O9VPP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-015-00	1 in 1 BOX	01/31/2018
1		50 mL in 1 BOTTLE; 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	01/31/2018

Labeler - NAOS (263520841)