LIKEWISE HAND MOISTURIZER - SUN PROTECTANT SPF 50- octinoxate, octisalate, zinc oxide cream

Likewise Hand Moisturizer - Sun Protectant SPF 50 by

Drug Labeling and Warnings

Likewise Hand Moisturizer - Sun Protectant SPF 50 by is a Otc medication manufactured, distributed, or labeled by Likewise Incorporated, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients..............Purpose
Octinoxate 7.50%............Sunscreen
Octisalate 5.00%.............Sunscreen
Zinc Oxide 11.16%..........Sunscreen

PURPOSE

Uses  - Helps prevent sunburn  - Higher SPF provides more protection  - Retains SPF after 40 minutes of activity in water or vigorous sweating.

WARNINGS

Warnings  For external use only

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION

Directions  - Apply daily 15 minutes before sun exposure and as needed  - Children under 6 months of age: ask a doctor.

PRECAUTIONS

Other information  Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

INACTIVE INGREDIENT

Inactive ingredients
Water, Caprylic/Capric Triglyceride, C15-19 Alkane, Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Butylene Glycol, Caprylyl Methicone, Glyceryl Stearate, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Peg-100 Stearate, Acrylated/C-12-22 Alkyl Methacrylate Copolymer, Lauroyl Lysine, Potassium Cetyl Phosphate, Dimethicone, Adipic Acid/Neopentyl Glycol Crosspolymer, Imperata Cylindrica Root Extract, Tridecyl Trimellitate, Hydrogenated Palm Glycerides, Glycerin, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Anhydroxylitol, Xylitol, Xylitylglucoside, Cetyl Hydroxyethylcellulose, Xanthan Gum, Moringa Pterygosperma Seed Extract, Secale Cereale (Rye) Seed Extract, Dextrin, Chlorphenesin, Tetrasodium EDTA, 1,2-Hexanediol, Algin, Atelocollagen, Caprylyl Glycol, Serine, Sodium Citrate, Tropolone, Niacinamide, PEG-8, Tocopheryl Acetate, Carbomer, Ascorbyl Tetraisopalmitate, DNA, Tocopherol, Genistein, VP/VA Copolymer, Amodimethicone, Hydroxypropyl Methylcellulose, Ethylbisiminomethylguaiacol Manganese Chloride.

DESCRIPTION

protect hydrate renew  . . . . . . .   NORMAL TO DRY SKIN  Daily moisturizer + Sunscreen  Dermatologist developed  Calms and softens dry, irritated skin with Niacinamide  Anti-aging antioxidants reverse daily damage and rejuvenate skin  Contains Vitamins B, C and E and Natural Soy to improve skin tone and texture  Works wonders as a nighttime moisturizer, too Non-greasy light coverage (apply 1 pea-size drop)  Delightfully fragrance free  . . . . . . .  LikewiseSkinCare.com  LIKEWISE INCORPORATED  200 COOL SPRINGS BOULEVARD  FRANKLIN, TENNESSEE 37067  IN CASE OF ADVERSE REACTION: 877.778.9546

PRINCIPAL DISPLAY PANEL

good morning sunshine Drug Facts

PRINCIPAL DISPLAY PANEL

hand MOISTURIZER + SUN PROTECTANT Fragrance Free  likewise with Zinc Soy and 50 SPF UVA/UVB - Water Resistant  ALL SKIN TYPES soothes and hydrates age-defying antioxidants contains vitamins B, C and E  85 mL (2.9 Fl.oz.)

PRINCIPAL DISPLAY PANEL

protect hydrate renew  ALL SKIN TYPES Daily moisturizer + Sunscreen Dermatologist developed Soothes and hydrates skin with Niacinamide Anti-aging antioxidants reverse daily damage and rejuvenate skin  Contains Vitamins B, C and E and Natural Soy to improve skin tone and texture  Non-greasy light coverage  Delightfully fragrance free LikewiseSkinCare.com  LIKEWISE INCORPORATED  200 COOL SPRINGS BOULEVARD  FRANKLIN, TENNESSEE 37067  IN CASE OF ADVERSE REACTION: 877.778.9546

PRINCIPAL DISPLAY PANEL

likewise hand MOISTURIZER + SUN PROTECTANT Fragrance Free ALL SKIN TYPES  likewise hand MOISTURIZER + SUN PROTECTANT Fragrance Free with Zinc Soy and 50 SPF UVA/UVB - Water Resistant ALL SKIN TYPES soothes and hydrates age-defying antioxidants contains vitamins B, C and E  85 mL (2.9 Fl.oz.)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIKEWISE HAND MOISTURIZER - SUN PROTECTANT SPF 50 
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76229-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	111.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HERRING SPERM DNA (UNII: 51FI676N6F)
TOCOPHEROL (UNII: R0ZB2556P8)
GENISTEIN (UNII: DH2M523P0H)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)
TRIDECYL STEARATE (UNII: A8OE252M6L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
LAUROYL LYSINE (UNII: 113171Q70B)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
ADIPIC ACID (UNII: 76A0JE0FKJ)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
XYLITOL (UNII: VCQ006KQ1E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
XANTHAN GUM (UNII: TTV12P4NEE)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
RYE (UNII: 0R4AQI398X)
ICODEXTRIN (UNII: 2NX48Z0A9G)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE SODIUM (UNII: MP1J8420LU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SERINE (UNII: 452VLY9402)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TROPOLONE (UNII: 7L6DL16P1T)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76229-123-01	1 in 1 PACKAGE	12/19/2017
1		85 mL in 1 BOTTLE; 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	06/20/2011

Labeler - Likewise Incorporated (027215523)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76229-123)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76229-123)