PROTECTIVE FOUNDATION SUNSCREEN SPF 15 402 FAIR IVORY- sunscreen, avobenzone, octinoxate emulsion 
Sunrider Manufacturing L.P.

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.

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Protective Foundation Sunscreen SPF 15-402

USES:

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

DIRECTIONS:

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

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:

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

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PROTECTIVE FOUNDATION SUNSCREEN SPF 15  402 FAIR IVORY
sunscreen, avobenzone, octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62191-402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.02 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 KindIngredient NameQuantity
May containTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
May containBROWN IRON OXIDE (UNII: 1N032N7MFO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62191-402-041 in 1 PACKAGE09/01/2016
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2016
Labeler - Sunrider Manufacturing L.P. (786951475)

Revised: 12/2021
Document Id: 93f027df-168a-4895-bc18-fee38f135e2e
Set id: dd1ae718-d131-456b-a2d1-f34c42d62fa8
Version: 6
Effective Time: 20211208
 
Sunrider Manufacturing L.P.