ELF Daily Hydration Moisturizer SPF 15 by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Daily Hydration Moisturizer SPF 15 by

Drug Labeling and Warnings

ELF Daily Hydration Moisturizer SPF 15 by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF DAILY HYDRATION MOISTURIZER SPF 15- octinoxate 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%

Octocrylene: 6.0%

Octisalate: 5.0%

Oxybenzene: 3.0%

Avobenzene: 3.0%

Purpose:

Sunscreen

Uses:

Helps 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.

Warning:

For external use only

D 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 of Reach of Children

Directions:

For suncreen use:

Apply liberally 15 min before sun exposure.

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

Inactive Ingredient:

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glycerin, Cetearyl Olivate, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Olivate, Cetearyl Alcohol, Stearic Acid, Cyclopentasiloxane,Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Phenoxyethanol, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Dimethicone, Tocopheryl Acetate (VE), Vitis Vinifera (Grape) Seed Oil, Bisabolol, Saccharum Offinarum (Sugar Cane) Extract, Vaccinium Myrtillus Fruit/leaf Extract, Citrus Sinensis (Orange) Fruit Extract, Acer Saccharum (Sugar Maple) Extact, Citrus Limon (Lemon) Fruit Extract

image description

second label

image description

ELF DAILY HYDRATION MOISTURIZER SPF 15 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.0 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DISODIUM HEDTA (UNII: KME849MC7A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)  
CITRUS SINENSIS FRUIT OIL (UNII: WV48LBL15Q)  
ACER SACCHARINUM WHOLE (UNII: 3PIN4S77JQ)  
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-801-0165 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/201712/05/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/04/201612/05/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 5/2017
 
J. A. Cosmetics U.S. INC