Label: NEUTROGENA PURE AND FREE BABY SUNSCREEN BROAD SPECTRUM SPF 50- zinc oxide lotion
- NDC Code(s): 69968-0275-3
- 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 13, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
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
- 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 value of SPF 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, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Glycerin, Polyhydroxystearic Acid, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
-
INGREDIENTS AND APPEARANCE
NEUTROGENA PURE AND FREE BABY SUNSCREEN BROAD SPECTRUM SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0275 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 216 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYL METHICONE (8 MPA.S) (UNII: 3YWG8XYT8H) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHLORPHENESIN (UNII: I670DAL4SZ) FEVERFEW (UNII: Z64FK7P217) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0275-3 88 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2016 Labeler - Johnson & Johnson Consumer Inc. (118772437)