Label: ELF BROAD SPECTRUM SPF 20 SUNSCREEN DARK BB CREAM- octinoxate cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 76354-614-01 - Packager: J. A. Cosmetics U.S. INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 17, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
For sunscreen use:
Apply generously 15 min before sun exposure. Reapply 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
-
INACTIVE INGREDIENT
Inactive Ingredient:
Water, Glycerin, Propylene Glycol, C12-15 Akyl Benzoate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quaternium-18, Bentonite, Triethoxycaprylsilane, Dimethicone, Zinc Stereate, Talc, VP/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone, Fragrance
May contain:
Iron Oxides (CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ELF BROAD SPECTRUM SPF 20 SUNSCREEN DARK BB CREAM
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76354-614 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM CHLORATE (UNII: T95DR77GMR) QUATERNIUM-18 (UNII: O7757NO1VL) BENTONITE (UNII: A3N5ZCN45C) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) ZINC STEARATE (UNII: H92E6QA4FV) TALC (UNII: 7SEV7J4R1U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ) JOJOBA OIL (UNII: 724GKU717M) CUCUMBER FRUIT OIL (UNII: R81Y52NPCT) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76354-614-01 28.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/10/2015 Labeler - J. A. Cosmetics U.S. INC (186705047) Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856) Establishment Name Address ID/FEI Business Operations Hangzhou Facecare Cosmetics Co., Ltd. 545341856 manufacture(76354-614)
