PROTECTIVE FOUNDATION SUNSCREEN SPF 15 414 FAIR BEIGE- 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 sunburn
• if used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun.

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
• 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

ACTIVE INGREDIENTS:

OCTINOXATE 6%
AVOBENZONE 2%

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

KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROTECTIVE FOUNDATION SUNSCREEN SPF 15  414 FAIR BEIGE
sunscreen, avobenzone, octinoxate emulsion

Product 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)