SHOPKO ABSOLUTE DAILY MOISTURIZING BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, homosalate, octinoxate, octocrylene cream

ShopKo Absolute Daily Moisturizing Broad Spectrum SPF15 Sunscreen by

Drug Labeling and Warnings

ShopKo Absolute Daily Moisturizing Broad Spectrum SPF15 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3.0%

Homosalate 3.0%

Oclisalate 5.0%

Octocrylene 2.6%

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under 6 months of age: 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, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Other Information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, glycerin, polyethylene, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, dimethicone, cetyl alcohol, cetearyl alcohol, cetearyl glucoside, panthenol (pro-vitamin B5), niacinamide, phenoxythanol, methylparaben, ethylparaben, propylparaben, stearyl alcohol, cyclopentasiloxane, dimethiconol, behenyl alcohol, tocopheryl acetate (vitamin E), DMDM hydantoin, benzyl alcohol, PEG-4 dilaurate, stearic acid, PEG-100 stearate, fragrance, disodium EDTA

Package/Label Principal Display Panel - Carton Label

Shopko*

*Compare to Olay® Complete All Day UV Moisturizer SPF15 Normal Skin Ingredients

SPF 15 Daily Moisturizer For Normal Skin
Light, Non-Greasy
With Vitamin E & Pro-Vitamin B5

• Dermatologically Tested
• Non-Comedogenic (won't clog pores)
• 100% Oil-Free
• 100% PABA-Free

Absolute Daily Moisturizer provides broad spectrum protection, moisture and vitamins, for beautiful, health-looking skin.

• Daily broad spectrum protection.
• Contains Pro-Vitamin B5 for moisturization and long-lasting hydration.
• Antioxidant vitamins C & E promotes and maintains healthy-looking skin.
• Lightweight and non-greasy.

DIRECTIONS FOR USE: Every day, apply liberally on face and neck, as often as necessary.

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Olay® Complete

4 FL OZ (118 mL)

Distributed by ShopKo Stores Operating Co., LLC
Green Bay, WI 54307
© 2013 ShopKo Stores Operating Co., LLC
Made in Israel. www.shopko.com

1D626 8C C1

Carton Label

INGREDIENTS AND APPEARANCE

SHOPKO ABSOLUTE DAILY MOISTURIZING BROAD SPECTRUM SPF15 SUNSCREEN 
avobenzone, homosalate, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-626
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PANTHENOL (UNII: WV9CM0O67Z)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
DOCOSANOL (UNII: 9G1OE216XY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PEG-4 DILAURATE (UNII: KCR71CW036)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-626-11	1 in 1 CARTON
1		118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2013

Labeler - Shopko Stores Operating Co., LLC (023252638)