SPF30 DAILY MOISTURIZER WITH SUNSCREEN- spf30 moisturizer with zinc oxide lotion

SPF30 Daily Moisturizer with Sunscreen by

Drug Labeling and Warnings

SPF30 Daily Moisturizer with Sunscreen by is a Otc medication manufactured, distributed, or labeled by PREP Cosmetics LLC, Richard Hamer Associates LLC, TAKA USA Inc dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide 22%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.

Directions

• Apply generously 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, sepacially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Allantoin, Dimethicone, Ethylhexylglycerin, Fragrance, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isononyl Isononanoate, Jojoba Oil, Neopentyl Glycol Dicaprate, Niacinamide, Polyacrylamide, Polyisobutylene, Polysorbate 20, Polysorbate 60, Potassium Sorbate, Propanediol, Squalane, Tocopherol, Triethoxycaprylylsilane, Water

Other Information

• protect this product from excessive heat and direct sun

Questions or Comments?

Call toll-free 1-800-4016031

www.prepyourskin.com

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INGREDIENTS AND APPEARANCE

SPF30 DAILY MOISTURIZER WITH SUNSCREEN 
spf30 moisturizer with zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70231-0020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	220 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALLANTOIN (UNII: 344S277G0Z)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70231-0020-3	1 in 1 CARTON	11/01/2016
1		60 mL 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	11/01/2016

Labeler - PREP Cosmetics LLC (053793815)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
TAKA USA Inc dba Cosmetic Innovations		802860515	manufacture(70231-0020) , pack(70231-0020)