Label: ANTI-AGING DAY PROTECT SPF 22- octinoxate, octisalate, and avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58400-006-01, 58400-006-02 - Packager: Pharmco Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 5, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
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Other Ingredients
Water, Propylene Glycol, Titanium Dioxide, Capric/Caprylic Triglycerides, Cetyl Alcohol, Glyceryl Stearate, PEG 100 Stearate, Polysorbate 60, Cetearyl Alcohol, Acetyl Hexapeptide-3, Aloe Barbadensis Leaf Extract, Disodium EDTA, Polysorbate 20, Sodium Hydroxide, Fragrance, Benzyl Alcohol, Camellia Sinensis (Green Tea) Extract, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Octyldodecanol, Squalane, Tocopheryl Acetate, Ubiquinone 50, Dimethicone, Diaminopropionoyl Tripeptide-33
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Skin Cancer/Skin Aging Alert & 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
This product has been shown to help prevent sun burn, not skin cancer or early skin aging.
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 87 g Tube Label
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INGREDIENTS AND APPEARANCE
ANTI-AGING DAY PROTECT SPF 22
octinoxate, octisalate, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 g Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 20 mg in 1 g Inactive Ingredients Ingredient Name Strength Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Aloe (UNII: V5VD430YW9) Benzyl Alcohol (UNII: LKG8494WBH) Ascorbic Acid (UNII: PQ6CK8PD0R) Green Tea Leaf (UNII: W2ZU1RY8B0) TRICAPRIN (UNII: O1PB8EU98M) TRICAPRYLIN (UNII: 6P92858988) Caprylyl Glycol (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Cetyl Alcohol (UNII: 936JST6JCN) Dimethicone 350 (UNII: 2Y53S6ATLU) Edetate Sodium (UNII: MP1J8420LU) Polyisobutylene (1000 Mw) (UNII: 5XB3A63Y52) Polysorbate 60 (UNII: CAL22UVI4M) Stearyl Alcohol (UNII: 2KR89I4H1Y) Glyceryl Monostearate (UNII: 230OU9XXE4) Hexylene Glycol (UNII: KEH0A3F75J) Octyldodecanol (UNII: 461N1O614Y) Squalane (UNII: GW89575KF9) Peg-100 Stearate (UNII: YD01N1999R) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 20 (UNII: 7T1F30V5YH) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Hydroxide (UNII: 55X04QC32I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Titanium Dioxide (UNII: 15FIX9V2JP) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58400-006-01 87 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2012 2 NDC:58400-006-02 3900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/01/2012 Labeler - Pharmco Laboratories Inc. (096270814) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories Inc. 096270814 MANUFACTURE(58400-006) , LABEL(58400-006) , PACK(58400-006) , ANALYSIS(58400-006)