Label: PROTECTIVE FOUNDATION SUNSCREEN SPF 15- sunscreen, avobenzone, octinoxate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 62191-007-02 - Packager: Sunrider Manufacturing L.P.
- 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 February 13, 2013
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- PURPOSE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
OTHER INGREDIENTS: WATER (DEIONIZED), GLYCERETH-26, CAPRYLIC/CAPRIC/STEARIC TRIGLLYCERIDE, ISOPROPYL PALMITATE, KAOLIN, PROPYLENE GLYCOL, POLYSORBATE 20, GLYCERYL STEARATE, STEARIC ACID, DIMETHICONE, PRUNUS AMYGDALUS DULCIS (SWEEK ALMOND)OIL, SIMMONDSIA CHINENSIS (JOJOBA) OIL, AHNFELTIA CONCINNA EXTRACT, SODIUM HYALURONATE, TOCOPHEROL, SORBITAN STEARATE, SORBITAN PALMITATE, CETYL ALCOHOL, BIS-DIGLYCERYL POLYACYLADIPATE-2, PHENOXYETHANOL, TRIETHANOLAMINE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, OLETH-20, SQUALENE (VEG ORIGIN), CORN STARCH MODIFIED, CELLULOSE GUM, CITRIC ACID, TRISODIUM EDTA, BUTYLENE, BUTYLPARABEN, MAY CONTAIN:TITANIUM DIOXIDE, IRON OXIDE.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECTIVE FOUNDATION SUNSCREEN SPF 15
sunscreen, avobenzone, octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62191-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.02 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength 1-BUTENE (UNII: LY001N554L) AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D) ALMOND OIL (UNII: 66YXD4DKO9) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE TRISODIUM (UNII: 420IP921MB) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) KAOLIN (UNII: 24H4NWX5CO) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) OLETH-20 (UNII: YTH167I2AG) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SQUALENE (UNII: 7QWM220FJH) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) TRICAPRIN (UNII: O1PB8EU98M) TRICAPRYLIN (UNII: 6P92858988) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62191-007-02 30 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2002 Labeler - Sunrider Manufacturing L.P. (786951475)