AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE lotion

baby by

Drug Labeling and Warnings

baby by is a Otc medication manufactured, distributed, or labeled by RETAIL BUSINESS SERVICES, LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (See Directions), decreases the rist of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

• on damaged or broken skin

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 liberaly 15 minutes before sun exposure
• apply to all skin exposed to the sun
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especialy from 10  a.m. -2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glyceryl stearate, benzyl alcohol, PEG-100 stearate, polyester-7, tocopherol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, chlorphenesin, beeswax, silica, neopentyl glycol diheptanoate, potassium hydroxide, disodium EDTA

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

(c)2019 S&S Brands, LLC Quality guaranteed or your money back

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

**Oxybenzone & Octinoxate free

Principal display panel

CareOne

Compare to Coppertine Sunscreen Lotion Water Babies SPF 50*

Baby Sunscreen Lotion

SPF 50 UVA/UVB protection

Broad Spectrum SPF 50

Water resistant (80 minutes)

Reef friendly

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-950
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYESTER-7 (UNII: 0841698D2F)
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
CHLORPHENESIN (UNII: I670DAL4SZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-950-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/08/2019

Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(72476-950)