PROTECTIVE FOUNDATION SUNSCREEN SPF 15- sunscreen, avobenzone, octinoxate emulsion

Protective Foundation Sunscreen SPF 15 by

Drug Labeling and Warnings

Protective Foundation Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by Sunrider Manufacturing L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

USES: HELPS PREVENT SUNBURNS.

DOSAGE & ADMINISTRATION

RECOMMENDATION:  PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

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

WARNINGS: FOR EXTERNAL USE ONLY, IF SWALLOWED SEEK MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY, IF CONTACT WITH EYES OCCURS, RINSE THOROUGHLY WITH WATER, DISCONTINUE USE AND CONSULT A DOCTOR IF PERSISTENT SIGNS OF IRRITATION OR RASH APPEAR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

carton

pump

INGREDIENTS AND APPEARANCE

PROTECTIVE FOUNDATION SUNSCREEN SPF 15 
sunscreen, avobenzone, octinoxate emulsion

Product 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)