ADAPTASUN SUN CARE SEA AND TROPICS FACE SPF 25- octinoxate, avobenzone cream

Adaptasun Sun Care Sea and Tropics Face SPF 25 by

Drug Labeling and Warnings

Adaptasun Sun Care 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 2.54%

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.

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.

Inactive Ingredients

Aqua/Water/Eau, Dicaprylyl Carbonate, Butyloctyl Salicylate, Glycerin, Dimethicone, Pongamia Glabra Seed Oil, Potassium Cetyl Phosphate, Vp/Eicosene Copolymer, Glyceryl Stearate, Peg-100 Stearate, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-Cresol, Caprylic/Capric, Trigly-Ceride, C20-22 Alkyl Phosphate, Creatine, Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Pongamol, C20-22 Alcohols, Fragrance (Parfum), Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trilinolein, Chlorphenesin, Acetyl Tyrosine, Aspartic Acid, Cerium Oxide, Helianthus Annuus (Sunflower) Seed Oil, Sodium Hydroxide, Disodium Edta, Sodium Dextran Sulfate, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Xanthan Gum, Butylene Glycol, Triolein, Tripalmitin, Hydrolyzed Wheat Protein, Oleic Acid, Propylene Glycol, Medicago Sativa (Alfalfa) Extract, Tristearin, Caprylyl Glycol, Copper Gluconate, Carnosine, Bht, Artemia Extract, Triarachidin, Algae Extract, Disodium Adenosine Triphosphate, Tocopherol, Potassium Sorbate, Acetyl Hexapeptide-1, Dextran, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Limonene, Benzyl Benzoate, Citronellol, Geraniol, Isoeugenol, Coumarin.

Question?

Call to 1-877-443-3762

Package Labeling:

INGREDIENTS AND APPEARANCE

ADAPTASUN SUN CARE SEA AND TROPICS FACE SPF 25 
octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-002
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	25.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
KARUM SEED OIL (UNII: 62160PU6FJ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CREATINE (UNII: MU72812GK0)
ENOXOLONE (UNII: P540XA09DR)
MANNITOL (UNII: 3OWL53L36A)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PONGAMOL (UNII: 8Y19QCY6I4)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TRILINOLEIN (UNII: V5LJ52OGS7)
CHLORPHENESIN (UNII: I670DAL4SZ)
N-ACETYLTYROSINE (UNII: DA8G610ZO5)
ASPARTIC ACID (UNII: 30KYC7MIAI)
CERIC OXIDE (UNII: 619G5K328Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
OLEOYL TYROSINE (UNII: 131P1BQX1U)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL TRIOLEATE (UNII: O05EC62663)
TRIPALMITIN (UNII: D133ZRF50U)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
OLEIC ACID (UNII: 2UMI9U37CP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALFALFA (UNII: DJO934BRBD)
TRISTEARIN (UNII: P6OCJ2551R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COPPER GLUCONATE (UNII: RV823G6G67)
CARNOSINE (UNII: 8HO6PVN24W)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIARACHIDIN (UNII: 48RPR95FW8)
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
BENZYL BENZOATE (UNII: N863NB338G)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
ISOEUGENOL (UNII: 5M0MWY797U)
COUMARIN (UNII: A4VZ22K1WT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-002-50	1 in 1 CARTON	10/04/2015
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	10/04/2015

Labeler - NAOS (263520841)