Label: SHEA MOISTURE SPF 35 MINERAL SUNSCREEN- zinc oxide, titanium dioxide cream
- NDC Code(s): 64942-1741-1
- Packager: CONOPCO INC. D/B/A/ UNILEVER
- 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 May 20, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses:
- Warnings:
- ASK DOCTOR
-
KEEP OUT OF REACH OF CHILDREN
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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: Ask a doctor
- Directions:
- Other Information:
-
Inactive Ingredients:
water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sorbitan tristearate, silica, stearyl/octyldodecyl citrate crosspolymer, VP/hexadecen copolymer, phenoxyethanol, magnesium sulfate, aloe barbadensis leaf juice, glycine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid.
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INGREDIENTS AND APPEARANCE
SHEA MOISTURE SPF 35 MINERAL SUNSCREEN
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64942-1741 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 30 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) OAT (UNII: Z6J799EAJK) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) HEXADECYL POVIDONE (UNII: AG75W62QYU) PHENOXYETHANOL (UNII: HIE492ZZ3T) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SOYBEAN (UNII: L7HT8F1ZOD) GLYCERIN (UNII: PDC6A3C0OX) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) JOJOBA OIL (UNII: 724GKU717M) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64942-1741-1 177 mL in 1 TUBE; Type 0: Not a Combination Product 04/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/18/2019 Labeler - CONOPCO INC. D/B/A/ UNILEVER (001375088) Registrant - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations FRUIT OF THE EARTH, INC. 080086802 manufacture(64942-1741)
