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NDC 49035-0969-11 EQUATE Sunscreen BABY Broad Spectrum SPF 50 30; 100; 60 mg/mL; mg/mL; mg/mL Details

EQUATE Sunscreen BABY Broad Spectrum SPF 50 30; 100; 60 mg/mL; mg/mL; mg/mL

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

Product Information

NDC	49035-0969
Product ID	49035-969_ec45595a-6d40-e79e-e053-2a95a90a5ce3
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 BABY Broad Spectrum SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone Homosalate Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 100; 60
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; 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 49035-0969-11 (49035096911)

Pricing Information	N/A
NDC Package Code	49035-969-11
Billing NDC	49035096911
Package	237 mL in 1 BOTTLE (49035-969-11)
Marketing Start Date	2017-01-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b2083cbd-ef19-4edc-9d7d-eca3452ee0ee Details

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octocrylene 6.0%

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

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 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, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone

Label

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN BABY BROAD SPECTRUM SPF 50

avobenzone homosalate octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-969
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
CETYL ALCOHOL (UNII: 936JST6JCN)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
COCO GLUCOSIDE (UNII: ICS790225B)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-969-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/10/2017

Labeler - WAL-MART STORES INC (051957769)

Revised: 10/2022

Document Id: ec45595a-6d40-e79e-e053-2a95a90a5ce3

Set id: b2083cbd-ef19-4edc-9d7d-eca3452ee0ee

Version: 3

Effective Time: 20221030