Label: WHITE GIRL SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70641-111-01 - Packager: White Girl, LLC
- 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 January 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
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Drug Facts
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 sun
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help
or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increasess your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf of 30 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 Information
protect this product from excessive heat and direct sun
- White Girl Sunscreen 30 SPF
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INGREDIENTS AND APPEARANCE
WHITE GIRL SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70641-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g in 100 g Inactive Ingredients Ingredient Name Strength STEARETH-21 (UNII: 53J3F32P58) 1.5 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70641-111-01 100 g in 1 POUCH; Type 0: Not a Combination Product 06/06/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/06/2016 Labeler - White Girl, LLC (080196333) Registrant - Bath Concept Cosmetics (Dongguan) Co., Ltd. (529623933) Establishment Name Address ID/FEI Business Operations Bath Concept Cosmetics (Dongguan) Co., Ltd. 529623933 manufacture(70641-111)