ADAPTASUN SUN CARE FACE SPF 15- octinoxate, avobenzone cream 
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 Cream Face SPF 15

Drug Facts

Active Ingredients

Octinoxate 4%

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 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.

Question or comments?

Call to 1 877 443 3762

Inactive Ingredients

Aqua/water/eau, dicaprylyl carbonate, glycerin, butyloctyl salicylate, dimethicone, pongamia glabra seed oil, potassium cetyl phosphate,  vp/eicosene copolymer, glyceryl stearate, peg-100 stearate, tocopheryl acetate, caprylic/capric triglyceride, c20-22 alkyl phosphate,  benzotriazolyl dodecyl p-cresol, creatine, glycyrrhetinic acid, mannitol, methylpropanediol, c20-22 alcohols, fragrance (parfum), phenoxyethanol, acrylates/c10-30 alkyl acrylate crosspolymer, trilinolein, chlorphenesin, acetyl tyrosine, aspartic acid, cerium oxide, pongamol, 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, propylene glycol, oleic acid, medicago sativa (alfalfa) extract, trilinolenin, tristearin, alcohol, caprylyl glycol, carnosine, copper gluconate, tris(tetramethylhydroxypiperidinol) citrate, artemia extract, bht, algae extract, disodium adenosine triphosphate, triarachidin, tocopherol, potassium sorbate, acetyl hexapeptide-1, dextran, linalool, hexyl cinnamal, hydroxycitronellal, limonene, benzyl benzoate, geraniol, citronellol, isoeugenol, coumarin.

Package Labeling:

outer

inner

ADAPTASUN SUN CARE FACE SPF 15 
octinoxate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14324-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
BENZYL BENZOATE (UNII: N863NB338G)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
ISOEUGENOL (UNII: 5M0MWY797U)  
COUMARIN (UNII: A4VZ22K1WT)  
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
CREATINE (UNII: MU72812GK0)  
ENOXOLONE (UNII: P540XA09DR)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
C20-22 ALCOHOLS (UNII: O4M0347C6A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRILINOLEIN (UNII: V5LJ52OGS7)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
N-ACETYLTYROSINE (UNII: DA8G610ZO5)  
ASPARTIC ACID (UNII: 30KYC7MIAI)  
CERIC OXIDE (UNII: 619G5K328Y)  
PONGAMOL (UNII: 8Y19QCY6I4)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OLEOYL TYROSINE (UNII: 131P1BQX1U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
TRIPALMITIN (UNII: D133ZRF50U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
OLEIC ACID (UNII: 2UMI9U37CP)  
ALFALFA (UNII: DJO934BRBD)  
TRILINOLENIN (UNII: OI7S0A9873)  
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)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14324-001-501 in 1 CARTON10/04/201510/31/2019
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 finalpart35210/04/201510/31/2019
Labeler - NAOS (263520841)

Revised: 8/2019
 
NAOS