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NDC 49035-0893-50 Equate Sunscreen SPF 50 BABY 30; 130; 50; 20 mg/g; mg/g; mg/g; mg/g Details

Equate Sunscreen SPF 50 BABY 30; 130; 50; 20 mg/g; mg/g; mg/g; mg/g

Equate Sunscreen SPF 50 BABY is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by WAL-MART STORES INC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	49035-0893
Product ID	49035-893_ec44433a-a66a-2762-e053-2995a90acd62
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Equate Sunscreen SPF 50 BABY
Proprietary Name Suffix	Broad Spectrum
Non-Proprietary Name	Avobenzone, Homosalate,Octisalate,Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 130; 50; 20
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	WAL-MART STORES INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0893-50 (49035089350)

Pricing Information	N/A
NDC Package Code	49035-893-50
Billing NDC	49035089350
Package	178 g in 1 CAN (49035-893-50)
Marketing Start Date	2016-11-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 91eb359d-f48f-480b-9b36-b0a8cfb30fac Details

Active Ingredients

Avobenzone 3.0%

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 2.0%

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. • Keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.

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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure

• Hold can 4-6 inches away from the skin to apply

• Do not spray directly into face. Spray into hands then apply to face

• Do not apply in windy conditions

• Use in a well-ventilated area

• 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 Broa 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

• may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

water, butyloctyl salicylate, sorbitol, VP/eicosene copolymer, stearic acid, aloe barbadensis leaf juice, panthenol, tocopherol, sorbitan isostearate, dimethicone, polyglyceryl-3 distearate, disodium EDTA, acrylates/C10-30 alkyl acrylate crosspolymer, styrene/acrylates copolymer, triethanolamine, benzyl alcohol, phenoxyethanol, capryloyl glycine, undecylenoyl glycine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN SPF 50 BABY BROAD SPECTRUM

avobenzone, homosalate,octisalate,octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-893
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
TROLAMINE (UNII: 9O3K93S3TK)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SORBITOL (UNII: 506T60A25R)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-893-50	178 g in 1 CAN; Type 0: Not a Combination Product	11/11/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/11/2016

Labeler - WAL-MART STORES INC (051957769)

Revised: 10/2022

Document Id: ec44433a-a66a-2762-e053-2995a90acd62

Set id: 91eb359d-f48f-480b-9b36-b0a8cfb30fac

Version: 3

Effective Time: 20221030