![WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]](https://medic.hrt.org//dailymed/images/9af87cf6-367a-45a6-8080-944713bbd3d6/Untitled.jpg)
| NDC | 55312-007-57 |
| Set ID | 9af87cf6-367a-45a6-8080-944713bbd3d6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | WESTERN FAMILY FOODS, INC. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- OTHER SAFETY INFORMATION
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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
- 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 of age: Ask a doctor
- Inactive ingredients
- Other information
- Questions or comments?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50
avobenzone,homosalate, octocrylene, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-007 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 WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-007-57 290 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/02/2014 Labeler - WESTERN FAMILY FOODS, INC. (192166072)
