Label: PROTECTIVE FOUNDATION SUNSCREEN SPF 15 414 FAIR BEIGE- sunscreen, avobenzone, octinoxate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 62191-414-04 - 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 December 8, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- PURPOSE
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DOSAGE & ADMINISTRATION
RECOMMENDATION: PLACE A SMALL AMOUNT ON A SPONGE, BLEND EVENLY OVER FACE
DIRECTIONS:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin againg. 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, expecially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
OTHER INGREDIENTS:
Water (Deionized)
Glycereth-26
Caprylic/Capric/Myristic/Stearic Triglyceride
Isopropyl Palmitate
Kaolin
Propylene Glycol
Polysorbate 20
Glyceryl Stearate
Stearic Acid (Veg. Origin)
Dimethicone
Prunus Amygdalus Dulcis (Sweet Almond) Oil
Simmondsia Chinensis (Jojoba) Seed Oil
Ahnfeltia Concinna Extract
Sodium Hyaluronate
Tocopherol
Sorbitan Stearate
Sorbitan Palmitate
Cetyl Alcohol
Bis-Diglyceryl Polyacyladipate-2
Phenoxyethanol
Triethanolamine
Magnesium Aluminum Silicate
Oleth-20
Squalane (Veg. Origin)
Corn Starch Modified
Cellulose Gum
Citric Acid
Trisodium EDTA
Butylene Glycol
Ethylhexylglycerin -
WARNINGS
WARNINGS:
FOR EXTERNAL USE ONLY
Do not use on damaged or broken skin
When using this product keep oout of eyes. Rinse with water to remove.
Sto use and ask a doctor if rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PROTECTIVE FOUNDATION SUNSCREEN SPF 15 414 FAIR BEIGE
sunscreen, avobenzone, octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62191-414 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 water (UNII: 059QF0KO0R) ALMOND OIL (UNII: 66YXD4DKO9) 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) AHNFELTIOPSIS CONCINNA (UNII: SMF2K46G8D) CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I) JOJOBA OIL (UNII: 724GKU717M) BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T) CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain TITANIUM DIOXIDE (UNII: 15FIX9V2JP) May contain BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62191-414-04 1 in 1 PACKAGE 09/01/2016 1 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/01/2016 Labeler - Sunrider Manufacturing L.P. (786951475)
