Label: BROAD SPECTRUM SPF 30 TINTED PHYSICAL DEFENSE SUNSCREEN- titanium dioxide and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81728-0624-1 - Packager: Advanced Body and Laser Center
- Category: HUMAN OTC DRUG LABEL
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 18, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENTS
- Purpose
- USES
- WARNINGS
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DIRECTIONS
Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: Ask a doctor. 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 a 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-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENTS
Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Polygonum Aviculare Extract, Tocopheryl Acetate, Perilla Frutescens Extract, Vitis Vinifera Fruit Cell Extract, Lepidium Sativum Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Simmondsia Chinensis (Jojoba) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499).
- OTHER INFORMATION
- Advanced Body and Laser Center Broad Spectrum SPF 30 Tinted Physical Defense Sunscreen 8 fl oz (240ml)
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 30 TINTED PHYSICAL DEFENSE SUNSCREEN
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81728-0624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.75 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ALUMINUM STEARATE (UNII: U6XF9NP8HM) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) SQUALANE (UNII: GW89575KF9) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) COCO GLUCOSIDE (UNII: ICS790225B) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) XANTHAN GUM (UNII: TTV12P4NEE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) JOJOBA OIL (UNII: 724GKU717M) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE STEARATE (UNII: 274KW0O50M) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH) PROPANEDIOL (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81728-0624-1 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/18/2021 Labeler - Advanced Body and Laser Center (025487743)