Label: OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN- zinc oxide lotion
- NDC Code(s): 21130-725-03
- Packager: SAFEWAY, 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 April 5, 2022
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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 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
- Other information
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Inactive ingredients
water, C12-15 alkyl benzoate, caprylic/capric triglyceride, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, phenyl trimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, polyhydroxystearic acid, glycerin, ethyl methicone, cetyl dimethicone, silica, colloidal oatmeal, chrysanthemum parthenium (feverfew) flower/leaf/stem juice, glyceryl behenate, phenethyl alcohol, caprylyl glycol, bis-divinyl dimethicone PEG-10 dimethicone crosspolymer, sodium chloride, phenoxyethanol, chlorphenesin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-725 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 216 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) DIMETHICONE (UNII: 92RU3N3Y1O) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERIN (UNII: PDC6A3C0OX) ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) OATMEAL (UNII: 8PI54V663Y) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) TANACETUM PARTHENIUM FLOWER (UNII: 7TVV9D7I89) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-725-03 89 mL in 1 TUBE; Type 0: Not a Combination Product 12/05/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/05/2018 Labeler - SAFEWAY, INC. (009137209)
