Label: CVS CHILDRENS BABYS SPF50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 69842-289-05
- Packager: CVS PHARMACY
- 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 June 18, 2021
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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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
• 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 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 - Other information
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Inactive Ingredients
water, caprylic/capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sodium chloride, ethylhexyl methoxycrylene, dimethicone, caprylyl glycol, PEG-8, silica, triethoxycaprylylsilane, glycerin, sodium citrate, tocopheryl acetate, aloe barbadensis leaf juice, propanediol, pentylene glycol, phenethyl alcohol
- Label
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INGREDIENTS AND APPEARANCE
CVS CHILDRENS BABYS SPF50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-289 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 31 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPANEDIOL (UNII: 5965N8W85T) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOHEXADECANE (UNII: 918X1OUF1E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SODIUM CITRATE (UNII: 1Q73Q2JULR) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) DIMETHICONE (UNII: 92RU3N3Y1O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-289-05 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/31/2018 Labeler - CVS PHARMACY (062312574)
