ADAPTASUN SUN CARE BODY SPF 15- octinoxate, avobenzone lotion 
NAOS

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 LOTION BODY SPF 15

Drug Facts

Active Ingredients

Octinoxate 4.5%

Avobenzone 2.5%

Purpose

Sunscreen

Uses

  • Help prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

AQUA/WATER, DICAPRYLYL CARBONATE, GLYCERIN, TRIBEHENIN PEG-20 ESTERS,CYCLOPENTASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, ETHYLHEXYL METHOXYCRYLENE, TOCOPHERYL ACETATE, PONGAMIA GLABRA SEED OIL, VP/EICOSENE COPOLYMER, HYDROXYETHYLACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, C20-22 ALKYL PHOSPHATE, BENZOTRIAZOLYL DODECYL P-CRESOL, CREATINE, GLYCERYL STEARATE, GLYCYRRHETINIC ACID, MANNITOL, METHYLPROPANEDIOL, PEG-100 STEARATE, C20-22 ALCOHOLS, FRAGRANCE (PARFUM), SQUALANE, PHENOXYETHANOL, TRILINOLEIN, CHLORPHENESIN, ACETYL TYROSINE, ASPARTIC ACID, CERIUM OXIDE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYETHYLENE, XANTHAN GUM, DISODIUM EDTA, SODIUM DEXTRAN SULFATE, POLYSILICONE-11, SODIUM HYDROXIDE,HYDROLYZED SOY PROTEIN, OLEOYL TYROSINE, BUTYLENE GLYCOL, TRIOLEIN, TRIPALMITIN, POLYSORBATE 60, HYDROLYZED WHEAT PROTEIN, OLEIC ACID, PROPYLENE GLYCOL, MEDICAGO SATIVA (ALFALFA) EXTRACT, TRILINOLENIN, TRISTEARIN, ALCOHOL, CAPRYLYL GLYCOL, CARNOSINE, COPPER GLUCONATE, TRIS (TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE, ARTEMIA EXTRACT, BHT, DISODIUM ADENOSINE TRIPHOSPHATE, TRIARACHIDIN, TOCOPHEROL, LAMINARIA DIGITATA EXTRACT, POTASSIUM SORBATE, ACETYL HEXAPEPTIDE-1, DEXTRAN, LINALOOL, HEXYL CINNAMAL, HYDROXYCITRONELLAL, LIMONENE, BENZYL BENZOATE, GERANIOL, CITRONELLOL, ISOEUGENOL, COUMARIN.

Package Labeling:

Outer PackageInner Package

ADAPTASUN SUN CARE BODY SPF 15 
octinoxate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
KARUM SEED OIL (UNII: 62160PU6FJ)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
CREATINE (UNII: MU72812GK0)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
PEG-100 STEARATE (UNII: YD01N1999R)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
SQUALANE (UNII: GW89575KF9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRILINOLEIN (UNII: V5LJ52OGS7)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
CERIC OXIDE (UNII: 619G5K328Y)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
OLEOYL TYROSINE (UNII: 131P1BQX1U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
TRIPALMITIN (UNII: D133ZRF50U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
OLEIC ACID (UNII: 2UMI9U37CP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALFALFA (UNII: DJO934BRBD)  
TRISTEARIN (UNII: P6OCJ2551R)  
ALCOHOL (UNII: 3K9958V90M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNOSINE (UNII: 8HO6PVN24W)  
COPPER GLUCONATE (UNII: RV823G6G67)  
TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G)  
TRIARACHIDIN (UNII: 48RPR95FW8)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
BENZYL BENZOATE (UNII: N863NB338G)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOEUGENOL (UNII: 5M0MWY797U)  
COUMARIN (UNII: A4VZ22K1WT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-010-001 in 1 BOX01/31/201810/31/2019
1150 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 finalpart35201/31/201810/31/2019
Labeler - NAOS (263520841)

Revised: 8/2019
Document Id: 90155d30-7c10-9d34-e053-2a95a90ac539
Set id: 64431eff-e7a6-2a22-e053-2991aa0aecf9
Version: 2
Effective Time: 20190814
 
NAOS