ELF SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE- octisalate cream 
J. A. Cosmetics U.S. 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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Drug Fact

Active Ingredient:

Octinoxate: 7.5%

Octisalate: 5%

Oxybenzone: 3%

Purpose:

Sunscreen

Uses:

Helps prevent sunburn

Warning:

For external use only

Skin Cancer/ Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown to only protect you from sunburn, not skin cancer or sking aging.

Do not use on damage or broken skin

When using this product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor if r ash occurs

Keep Out of Reach of Children

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure.

Apply to clean skin in an upward and outward motion with sponage or foundation brush

Children under six months of age: ask a doctor.

Reapply at least every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

  • Limit time in the sun, especially from 10 am to 2 pm
  • Wear long sleeved shirts, pants, hats, and sunglasses.
  • Children under six months of age: ask a doctor

Other Information:

Protect this product in the container from excessive heat and direct sun

Store at room temperature 15-30 C (59-86F)

Inactive Ingredient:

Water, Dimethicone, Propylene Glycol,  C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Steareth-21, Steareth-2, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Xantahn Gum, Retinyl Palmitate (VA), Ascorbyl Palmitate (VC), Tocopheryl Acetate (VE), Butylene Glycol, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract

May contain:

Titanium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)

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ELF SPF 20 SUNSCREEN UVAUVB TINTED MOISTURIZER NUDE 
octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-633
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-21 (UNII: 53J3F32P58)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
XANTHAN GUM (UNII: TTV12P4NEE)  
VITAMIN A (UNII: 81G40H8B0T)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
STEARETH-2 (UNII: V56DFE46J5)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-633-0125 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/19/201901/31/2021
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture(76354-633)

Revised: 11/2021
 
J. A. Cosmetics U.S. INC