ELF BB SPF-20- oxybenzone, octisalate and 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.

----------

Active Ingredient:

OXIBENZONE: 4%

OCTISALATE: 5%

OCTINOXATE: 7.5%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin aging.

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:

  • Apply generally 15 minutes before sun exposure.
  • Children under six months of age; ask a doctor.
  • Reapply at least every two hours
  • Use a water resistant sunscreen if swimming or sweating

Other Information

  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
  • STORE AT ROOM TEMPERATURE 15°C-30°C (59°F-86°F)

Inactive Ingredient:

WATER (AQUA), GLYCERIN, PROPYLENE GLYCOL, C12-15 ALKYL BENZOATE, TITANIUM DIOXIDE, CETYL PEG/PPG-10/1 DIMETHICONE, CYCLOHEXASILOXANE, SORBITAN OLIVATE, POLYMETHYL METHACRYLATE, SODIUM CHLORIDE, QUATERNIUM-18 BENTONITE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, ZINC STEARATE, TALC, VP/HEXADECENE COPOLYMER, BISABOLOL, TOCOPHERYL ACETATE (VE), SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, MICA, SILICA, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, METHYLISOTHIAZOLINONE

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499)

ELF_BB Cream_Artwork_Tube

ELF_BB Cream_Artwork_Beige

ELF_BB Cream_Artwork_Buff

ELF_BB Cream_Artwork_Dark

ELF_BB Cream_Artwork_Fair

ELF_BB Cream_Artwork_Medium

ELF_BB Cream_Artwork_Nude

ELF BB  SPF-20
oxybenzone, octisalate, and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5   in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
C12-15 ALKYL BENZOATE 
TITANIUM DIOXIDE 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) 
CYCLOMETHICONE 6 
CYCLOMETHICONE 5 
SORBITAN OLIVATE 
POLY(METHYL METHACRYLATE; 450000 MW) 
SODIUM CHLORIDE 
QUATERNIUM-18 HECTORITE 
TRIETHOXYCAPRYLYLSILANE 
DIMETHICONE 
ZINC STEARATE 
TALC 
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) 
.ALPHA.-BISABOLOL, (+/-)- 
.ALPHA.-TOCOPHEROL ACETATE 
JOJOBA OIL 
ALOE VERA LEAF 
CUCUMBER 
MICA 
SILICON 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-101-511 in 1 BOX
1NDC:76354-101-1130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/10/2013
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-101)

Revised: 10/2013
 
J. A. Cosmetics U.S. INC