Label: BABYGANICS SUNSCREEN 30 SPF- zinc oxide, octinoxate, and octisalate spray
- NDC Code(s): 59062-1229-1
- Packager: KAS Direct LLC dba BabyGanics
- 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 February 5, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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
- 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, caprylic/capric triglyceride, glycerin, vp/hexadecene copolymer, aloe barbadensis leaf juice, glyceryl stearate, hexaglyceryl polyricinoleate, polysorbate 80, phenethyl alcohol, glyceryl caprylate, sodium magnesium silicate, xanthan gum, hydroxyethyl acrylate/sodium acryloyldimethyltaurate copolymer, squalane, citric acid, lecithin, polysorbate 60, sorbitan isostearate.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
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INGREDIENTS AND APPEARANCE
BABYGANICS SUNSCREEN 30 SPF
zinc oxide, octinoxate, and octisalate sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1229 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 50 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) HEXADECYL POVIDONE (UNII: AG75W62QYU) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) SODIUM MAGNESIUM FLUOROSILICATE (UNII: U1QJ22MC8E) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59062-1229-1 177 mL in 1 BOTTLE, DISPENSING; 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 06/21/2013 Labeler - KAS Direct LLC dba BabyGanics (002764605)
