DAILY PROTECTING SPF15 SUNSCREEN- lotion lotion

Daily Protecting SPF15 Sunscreen by

Drug Labeling and Warnings

Daily Protecting SPF15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Autumn Harp Inc., Autumn Harp Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide (10.0%)

Purpose

Sunscreen

Uses:

Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

For external use only. Do not use on damaged or broken skin When using this product, keep out of eyes. Rinse with water to remove Stop 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.

Directions:

For full protection, 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 aging. 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, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients:

Water, Coco caprylate, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Glycerin, Niacinamide, Magnesium Aluminum Silicate, Sucrose Cocoate, Phenoxyethanol, Xanthan Gum, Gluconolactone, Tripeptide 29, Laminaria Digitata Powder, Tocopherol, Lecithin, Codium Fragile Extract, Fragrance, Flavor, Linalool, Porphyridium Cruentum Exsuded Culture Medium, Leuconostoc Radish Root Ferment Filtrate, Citral, Geraniol, Bladderwrack Powder, Sodium Benzoate, Citric Acid, Potassium Sorbate, Citronellol

Other Information:

Protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-877-317-3106

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INGREDIENTS AND APPEARANCE

DAILY PROTECTING SPF15 SUNSCREEN 
lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PORPHYRIDIUM PURPUREUM (UNII: K2P8K2558N)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
CITRAL (UNII: T7EU0O9VPP)
GERANIOL (UNII: L837108USY)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ISOEUGENOL (UNII: 5M0MWY797U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
CODIUM FRAGILE (UNII: MSE6FUU012)
LINALOOL, (+)- (UNII: F4VNO44C09)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FARNESOL (UNII: EB41QIU6JL)
EUGENOL (UNII: 3T8H1794QW)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
COCONUT OIL (UNII: Q9L0O73W7L)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SUCROSE COCOATE (UNII: 3H18P0UK73)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0352-1	1 g in 1 TUBE; Type 0: Not a Combination Product	08/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/31/2016

Labeler - Autumn Harp Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp Inc		064187883	manufacture(51514-0352)