NDC | 36800-870-06 |
Set ID | 94a11f26-2de6-446f-8122-d82b2d64f5ee |
Category | HUMAN OTC DRUG LABEL |
Packager | TopCo |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients Purpose
- PURPOSE
- INDICATIONS & USAGE
- 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
• 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 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-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions? 1-888-423-0139
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BABY GENTLE SUNSCREEN SPF 50
avobenzone - 3.0% homosalate - 13.0% octisalate - 5.0% octocrylene - 7.0% oxybenzone 4% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-870 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 13 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 7 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 4 g in 100 mL Inactive Ingredients Ingredient Name Strength Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Benzyl Alcohol (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Methylparaben (UNII: A2I8C7HI9T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Propylparaben (UNII: Z8IX2SC1OH) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-870-06 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/21/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/21/2016 Labeler - TopCo (006935977) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(36800-870) , label(36800-870)