Adaptasun Sea and Tropics Protective Body Lotion SPF 30

Adaptasun Sea and Tropics Protective Body SPF 30 by

Drug Labeling and Warnings

Adaptasun Sea and Tropics Protective Body SPF 30 by is a Otc medication manufactured, distributed, or labeled by Naos USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ADAPTASUN SEA AND TROPICS PROTECTIVE BODY SPF 30- homosalate, octisalate, avobenzone lotion 
Naos USA, Inc.

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Adaptasun Sea and Tropics Protective Body Lotion SPF 30

Drug Facts

Active ingredients (w/w)

Homosalate 9%

Octisalate 4.5%

Avobenzone 2.7%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only.

Do not use

on 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 of reach of children.

If swallowed, call a poison control centre 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.; and  wear long-sleeve shirts, pants, hats and sunglasses.  Children under 6 months of age: ask a doctor.

Other information

Keep the product between 15-30°C (59-86°F).  Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water, Ethylhexyl Methoxycrylene, Dicaprylyl Carbonate, Glycerin, Tribehenin Peg-20 Esters, Dimethicone, Butyloctyl Salicylate, Tocopheryl Acetate, Benzotriazolyl Dodecyl P-Cresol, Silica, Vp/Eicosene Copolymer, C20-22 Alkyl Phosphate, Creatine, Fragrance (Parfum), Glyceryl Stearate, Glycyrrhetinic Acid, Mannitol, Methylpropanediol, Peg-100 Stearate, Pentylene Glycol, Soybean Glycerides, C20-22 Alcohols, Polysilicone-11, Xanthan Gum, Caprylyl Glycol, 1,2-Hexanediol, Acetyl Tyrosine, Aspartic Acid, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Sodium Dextran Sulfate, Sodium Hydroxide, Hydrolyzed Soy Protein, Oleoyl Tyrosine, Hydrolyzed Wheat Protein, Luffa Cylindrica Seed Oil, Linalool, Hexyl Cinnamal, Hydroxycitronellal, Oleaic Acid, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Propylene Glycol, Butylene Glycol, Aminoethanesulfinic Acid, Phenoxyethanol, Limonene, Benzyl Benzoate, Geraniol, Copper Gluconate, Citronellol, Carnosine, Tocopherol, Isoeugenol, Coumarin, Disodium Adenosine Triphosphate, Artemia Extract, Medicago Sativa (Alfalfa) Extract, Laminaria Digitata Extract, Citral, Acetyl Hexapeptide-1, Dextran. [ES867]

Questions?

Call 1-877-443-3762

Package Labeling:

ADAPTASUN SEA AND TROPICS PROTECTIVE BODY SPF 30 
homosalate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14324-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL BENZOATE (UNII: N863NB338G)
GERANIOL (UNII: L837108USY)
COPPER GLUCONATE (UNII: RV823G6G67)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CARNOSINE (UNII: 8HO6PVN24W)
TOCOPHEROL (UNII: R0ZB2556P8)
ISOEUGENOL (UNII: 5M0MWY797U)
COUMARIN (UNII: A4VZ22K1WT)
MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CITRAL (UNII: T7EU0O9VPP)
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
GLYCERIN (UNII: PDC6A3C0OX)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CREATINE (UNII: MU72812GK0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ENOXOLONE (UNII: P540XA09DR)
MANNITOL (UNII: 3OWL53L36A)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACETYL L-TYROSINE (UNII: DA8G610ZO5)
ASPARTIC ACID (UNII: 30KYC7MIAI)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
OLEOYL TYROSINE (UNII: 131P1BQX1U)
LUFFA AEGYPTIACA SEED OIL (UNII: 1A281RJ859)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
OLEIC ACID (UNII: 2UMI9U37CP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYPOTAURINE (UNII: 5L08GE4332)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14324-028-00	1 in 1 CARTON	04/01/2023	09/30/2024
1		150 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 Drug	M020	04/01/2023	09/30/2024

Labeler - Naos USA, Inc. (080727572)

Revised: 11/2023

Document Id: 0b41e4c6-3d51-2689-e063-6394a90a3f70

34390-5

Set id: 21e36dea-3769-4e4b-bf78-d14d8f9d9d1d

Version: 2

Effective Time: 20231128