Label: BROAD SPECTRUM SPF 30 UP THE ANTI- titanium dioxide, zinc oxide cream
- NDC Code(s): 42485-005-01
- Packager: Biopelle, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- Broad Spectrum SPF 30 Up The Anti
- Active Ingredients
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
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Directions
- apply to face and under throat after cleansing
- reapply:
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- after excessive perspiration
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: Sun Protection Measures.
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- 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
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Inactive Ingredients
water, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.
- Other Information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- Broad Spectrum SPF 30 Up The Anti 75ml (42485-005-01)
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 30 UP THE ANTI
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42485-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 32 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ALUMINUM OXIDE (UNII: LMI26O6933) ISOHEXADECANE (UNII: 918X1OUF1E) BORON NITRIDE (UNII: 2U4T60A6YD) SODIUM LEVULINATE (UNII: VK44E1MQU8) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM ANISATE (UNII: F9WFJ28MV9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PANTHENOL (UNII: WV9CM0O67Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) ALOE VERA LEAF (UNII: ZY81Z83H0X) DMDM HYDANTOIN (UNII: BYR0546TOW) ALLANTOIN (UNII: 344S277G0Z) EDETATE SODIUM (UNII: MP1J8420LU) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) BUTYLPARABEN (UNII: 3QPI1U3FV8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42485-005-01 75 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/19/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/14/2012 Labeler - Biopelle, Inc. (808158823) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 172198223 manufacture(42485-005)