![BABYGANICS SUNSCREEN 30 SPF (ZINC OXIDE, OCTINOXATE, AND OCTISALATE) SPRAY [KAS DIRECT LLC DBA BABYGANICS]](https://medic.hrt.org//dailymed/images/391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1/babyganics-01.jpg)
| NDC | 59062-1229-1 |
| Set ID | 391a4ec3-b65b-4dbe-bc8f-cb67514c8ef1 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | KAS Direct LLC dba BabyGanics |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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
-
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
-
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
-
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)
