Label: SUN DEFEATED SUNSCREEN- avobenzone, octocrylene, oxybenzone, octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51702-114-01, 51702-114-02 - Packager: Mission
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 March 12, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients: Purpose:
Avobenzone (3.0%)..............................................................Sunscreen
Octocrylene (7.0%)...............................................................Sunscreen
Oxybenzone (4.0%)...............................................................Sunscreen
Octisalate (8.0%)...................................................................Sunscreen
- PURPOSE
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WARNINGS
Warnings: FOR EXTERNAL USE ONLY
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.
- When using this product keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 deg F.
- Stop use and ask a doctor if skin rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- When using this product keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 deg F.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aqua (Deionized Water), Glyceryl Stearate, Isopropyl Palmitate, Stearic Acid, PEG 100 Stearate, C 12-15 Alkyl Benzoate, Acrylates/C12-22 Alkylmethacrylates Copolymer, Sorbitol, Marshmallow Extract, Ivy Extract, Cucumber Extract, Elder Flower, Arnica Extract, Tocopheryl Acetate, Acrylates Copolymer, Cetyl Alcohol, Dimethicone, VP/Hexadecene Copolymer, Aloe Barbadenis Leaf Juice, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, EDTA, Phenoxyethanol, Ethylhexylglycerin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN DEFEATED SUNSCREEN
avobenzone, octocrylene, oxybenzone, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51702-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 2.79 g in 93 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 6.51 g in 93 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 3.74 g in 93 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 7.44 g in 93 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) STEARIC ACID (UNII: 4ELV7Z65AP) PEG-100 STEARATE (UNII: YD01N1999R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SORBITOL (UNII: 506T60A25R) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) HEDERA HELIX LEAF (UNII: ZP9XFG71A7) CUCUMBER JUICE (UNII: 61845009SP) SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) ARNICA MONTANA (UNII: O80TY208ZW) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) EDETIC ACID (UNII: 9G34HU7RV0) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51702-114-02 1 in 1 BOX 1 NDC:51702-114-01 93 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/12/2012 Labeler - Mission (831230425)
