NDC | 68016-270-06 |
Set ID | aa0dd1e0-1422-4bcc-bb2f-1f1e75b96708 |
Category | HUMAN OTC DRUG LABEL |
Packager | Premier Value |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
-
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
- Inactive Ingredients
- Other Information
- Questions? 866-483-2846
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 50
avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-270 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 13 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 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) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-270-06 227 g in 1 BOTTLE; Type 0: Not a Combination Product 04/26/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/26/2012 Labeler - Premier Value (101668460) Registrant - Product Quest Mfg, LLC (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg, LLC 927768135 manufacture(68016-270) , label(68016-270)