WOLF DAILY MOISTURIZIER SPF 15- octinoxate, oxybenzone, zinc oxide lotion

Wolf Daily Moisturizier SPF 15 by

Drug Labeling and Warnings

Wolf Daily Moisturizier SPF 15 by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 2%, Oxybenzone 4%, Zince Oxide 3.8%

Purpose

Sunscreen

Use(s)

• 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

​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 Broad Spectrum SPF value of 15 or higher and other sun protection measure including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.
• use a water resistant sunscreen if swimming or sweating.
• reapply at least every 2 hours.
• children under 6 months: ask doctor

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Water (Aqua), Butylene Glycol Cocoate, Neopentyl Glycol Diheptanoate, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Glycerin, Acetamidoethoxyethanol, Potassium Cetyl Phosphate, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Polysorbate 80, Isohexadecane, Benzyl Alcohol, Xanthan Gum, Tetrasodium Glutamate Diacetate, Fragrance (Parfum), Lactic Acid, Triethoxycaprylylsilane, Tetrahexydecyl Ascorbate, Crambe Abyssinica Seed Oil, Panthenol, Hydrolyzed Keratin, Camellia Sinensis Leaf Extract, Aspalathus Linearis Leaf Extract, Aloe Barbadensis Leaf Juice, Pinus Pinaster Bark Extract, Hydrolyzed Adansonia Digitata Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Hydrolyzed Hemp Protein, Hydrolyzed Vegetable Protein, Ascorbyl Glucoside, Phytonadione, Niacinamide, Cyanocobalamin, Tocopheryl Acetate, Iodopropynyl Butylcarbamate.

Questions?

Call toll-free 1-855-760-3569

Label Copy

INGREDIENTS AND APPEARANCE

WOLF DAILY MOISTURIZIER SPF 15 
octinoxate, oxybenzone, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	38 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOHEXADECANE (UNII: 918X1OUF1E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
LACTIC ACID (UNII: 33X04XA5AT)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PANTHENOL (UNII: WV9CM0O67Z)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MARITIME PINE (UNII: 50JZ5Z98QY)
ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)
TEA TREE OIL (UNII: VIF565UC2G)
CANNABIS SATIVA SEED (UNII: QE567Z26NG)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
PHYTONADIONE (UNII: A034SE7857)
NIACINAMIDE (UNII: 25X51I8RD4)
CYANOCOBALAMIN (UNII: P6YC3EG204)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-008-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Labeler - Apollo Health and Beauty Care Inc. (201901209)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-008)