ADAPTASUN SUN CARE SEA AND TROPICS FACE SPF 25- octinoxate, avobenzone cream 
Naos USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Adaptasun Sun Care Cream Sea and Tropics Face SPF 25

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

avoid contact with eyes. If contact occurs. rinse thoroughly with water.

Stop use and ask a doctor if

rash occurs.

Keep out reach of children.

If swallowed, call a poison control center or get medical help right away.

Directions

Adults 18 years and older:

  • Apply liberally and evenly 15 minutes 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 (59-86ºF).
  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

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:

Outer LabelInner Label

ADAPTASUN SUN CARE SEA AND TROPICS FACE SPF 25 
octinoxate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)  
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)  
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TRILINOLENIN (UNII: OI7S0A9873)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-002-501 in 1 CARTON10/04/201508/31/2022
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/04/201508/31/2022
Labeler - Naos USA, Inc. (080727572)

Revised: 10/2022
 
Naos USA, Inc.