EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF70 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Equate Beauty Ultra Light Sunscreen SPF70 by

Drug Labeling and Warnings

Equate Beauty Ultra Light Sunscreen SPF70 by is a Otc medication manufactured, distributed, or labeled by WALMART STORES INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

AVOBENZONE 3.0%

HOMOSALATE 10 .0%

OCTISALATE 3.0%

OCTOCRYLENE 7.0%

OXYBENZONE 6.0%

Purpose

AVOBENZONE 3.0%     Sunscreen

HOMOSALATE 10.0%   Sunscreen

OCTISALATE 3.0%      Sunscreen

OCTOCRYLENE 7.0%    Sunscreen

OXYBENZONE 6.0%    Sunscreen

Uses

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

Warnings

For external use only.

Do not use  - 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
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
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 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

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

water, styrene/acrylates copolymer, dimethicone, acrylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xantham gum, caprylyl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6,phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA,  and fragrance

PRINCIPAL DISPLAY PANEL

Equate Beauty Ultra Light Sunscreen SPF70 Lotion

Product NDC: 49035-629

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF70  BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-629
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	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
ACRYLIC ACID (UNII: J94PBK7X8S)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)
POLYSILICONE-15 (UNII: F8DRP5BB29)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-629-09	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/17/2019

Labeler - WALMART STORES INC. (051957769)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		080086802	manufacture(49035-629)