Label: AVEENO PROTECT PLUS SOOTHE FACE MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 69968-0786-2
- Packager: Johnson & Johnson Consumer 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 January 16, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
Water, Isohexadecane, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dimethicone, Ethylhexyl methoxycrylene, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Calcium Aluminum Borosilicate, VP/Hexadecene Copolymer, Styrene/Acrylates Copolymer, Triethoxycaprylylsilane, Aluminum Hydroxide, Xanthan Gum, Stearic Acid, Trisiloxane, Polyester-7, Phenoxyethanol, Polyhydroxystearic Acid, Caprylyl Glycol, Ethylhexylglycerin, Neopentyl Glycol Diheptanoate, Behenyl Alcohol, Glycerin, Disodium EDTA, Silica, Tocopheryl Acetate, Avena Sativa (Oat) Kernel Extract
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50mL Carton Label
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INGREDIENTS AND APPEARANCE
AVEENO PROTECT PLUS SOOTHE FACE MINERAL SUNSCREEN SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0786 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 66 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 180 mg in 1 mL Inactive Ingredients Ingredient Name Strength OAT (UNII: Z6J799EAJK) WATER (UNII: 059QF0KO0R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) XANTHAN GUM (UNII: TTV12P4NEE) TRISILOXANE (UNII: 9G1ZW13R0G) ISOHEXADECANE (UNII: 918X1OUF1E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DOCOSANOL (UNII: 9G1OE216XY) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) DIMETHICONE (UNII: 92RU3N3Y1O) POLYESTER-7 (UNII: 0841698D2F) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0786-2 1 in 1 CARTON 12/06/2022 1 50 mL in 1 TUBE; 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 12/06/2022 Labeler - Johnson & Johnson Consumer Inc. (118772437)