Label: BABYGANICS SPF 50- octinoxate, octisalate, and zinc spray
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0235-1 - Packager: Autumn Harp, 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 November 15, 2018
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- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children
- Directions
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Sun Protection Measures
Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin aging. To decrease this risk sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 am - 2 pm.
wear long-sleeved shirts, pants, hats, andsunglasses
- Other Information
- Inactive ingredients
- Label
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INGREDIENTS AND APPEARANCE
BABYGANICS SPF 50
octinoxate, octisalate, and zinc sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0235 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 112 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0235-1 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/21/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/23/2012 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0235)