Label: PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, oxybenzone, octisalate, octocrylene, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-2076-1, 67938-2076-2 - Packager: ELIZABETH ARDEN, INC
- 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 February 1, 2017
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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 the sun
- Warnings
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Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:
- At least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
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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.
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Inactive Ingredients
WATER/AQUA/EAU, NYLON-12, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, PENTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLYL METHICONE, ACETYL FARNESYLCYSTEINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAPRYLYL GLYCOL, CARNOSINE, CETETH-20 PHOSPHATE, CHONDRUS CRISPUS EXTRACT, COCO-GLUCOSIDE, DICETYL PHOSPHATE, DISODIUM EDTA, ERGOTHIONEINE, HYDROXYACETOPHENONE, LECITHIN, MICROCOCCUS LYSATE, PLANKTON EXTRACT, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE.
- Other Information
- Questions or comments?
- Principal Display Panel - Bottle Label
- Principal Display Panel - Carton Label
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INGREDIENTS AND APPEARANCE
PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN
octinoxate, oxybenzone, octisalate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-2076 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .07575 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE .06 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE .0505 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE .0525 g in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE .03237 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NYLON-12 (UNII: 446U8J075B) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PENTYLENE GLYCOL (UNII: 50C1307PZG) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CETETH-20 PHOSPHATE (UNII: 921FTA1500) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) COCO GLUCOSIDE (UNII: ICS790225B) CARNOSINE (UNII: 8HO6PVN24W) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ERGOTHIONEINE (UNII: BDZ3DQM98W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-2076-1 1 in 1 BOX 02/01/2017 1 NDC:67938-2076-2 120 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 Labeler - ELIZABETH ARDEN, INC (849222187)
