Label: WALGREENS BABY SPF50- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-9936-26 - Packager: Walgreen Company
- 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 August 30, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- helps prevent sunburn
- 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
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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 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
- apply liberally 15 minutes before sun exposure
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Inactive Ingredients
Deionized Water, Caprylic/Capric Triglycerides, Tridecyl Neopentanoate, Sorbitol, Cetyl PEG/PPG 10/1 Dimethicone, Butly Octyl Salicylate, Glycerin, Octyldodecyl Citrate Copolymer, C28-52 Olefin/Undecylenic Acid Copolymer, PEG 8, Dimethicone, Aloe Barbadensis Leaf Juice, Ethylhexyl Methoxycrylene, Tocopherol Acetate, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Sodium Chloride, Phenoxyethanol, Sodium Citrate
- Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WALGREENS BABY SPF50
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-9936 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.1 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5) SORBITOL (UNII: 506T60A25R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-9936-26 178 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/15/2017 Labeler - Walgreen Company (008965063) Registrant - Walgreen Company (008965063)
