Label: OP DARK FORMULA XTREME TANNING 4- octinoxate, octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62802-600-08 - Packager: Sun & Skin Care Research, 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 May 21, 2012
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- Active Ingredients
- Purpose
- Uses
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Warnings
Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or call a poison control center right away.
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INGREDIENTS AND APPEARANCE
OP DARK FORMULA XTREME TANNING 4
octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62802-600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 mL in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CARAMEL (UNII: T9D99G2B1R) CANOLA OIL (UNII: 331KBJ17RK) OLIVE OIL (UNII: 6UYK2W1W1E) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SUNFLOWER OIL (UNII: 3W1JG795YI) BUTYLPARABEN (UNII: 3QPI1U3FV8) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62802-600-08 251 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2012 Labeler - Sun & Skin Care Research, LLC (849772207) Establishment Name Address ID/FEI Business Operations Sun & Skin Care Research, LLC 849772207 manufacture