Label: NEUTROGENA HEALTHY SKIN FACE SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, and oxybenzone lotion
- NDC Code(s): 69968-0299-2
- 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 March 23, 2023
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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
- Warnings
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Directions
For sunscreen use:
- apply generously and evenly 15 minutes before sun exposure
- reapply atleast every 2 hours
- use a water resistant sunscreen if swimming or sweating
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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 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, glycolic acid, dicaprylyl maleate, C12-15 alkyl benzoate, stearic acid, glycerin, cetyl alcohol, PEG-100 stearate, glyceryl stearate, sodium hydroxide, phenoxyethanol, sclerotium gum, tocopheryl acetate, caprylyl glycol, fragrance, xanthan gum, methylparaben, panthenol, bisabolol, propylparaben, tetrasodium EDTA, ascorbic acid
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
NEUTROGENA HEALTHY SKIN FACE SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0299 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIOCTYL MALEATE (UNII: OD88G8439L) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) BETASIZOFIRAN (UNII: 2X51AD1X3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) METHYLPARABEN (UNII: A2I8C7HI9T) PANTHENOL (UNII: WV9CM0O67Z) LEVOMENOL (UNII: 24WE03BX2T) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0299-2 1 in 1 CARTON 04/01/2014 07/31/2025 1 73 mL in 1 BOTTLE; 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 04/01/2014 07/31/2025 Labeler - Johnson & Johnson Consumer Inc. (118772437)