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NDC 49035-0962-28 Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 50; 100; 150 mg/g; mg/g; mg/g Details

Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 50; 100; 150 mg/g; mg/g; mg/g

Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50 is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is HOMOSALATE; OCTOCRYLENE; ZINC OXIDE.

Product Information

NDC	49035-0962
Product ID	49035-962_c6b34a92-eff7-4d77-e053-2a95a90a683f
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 Mineral Based KIDS Broad Spectrum spf 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Homosalate , Octocrylene, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	STICK
Route	TOPICAL
Active Ingredient Strength	50; 100; 150
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0962-28 (49035096228)

Pricing Information	N/A
NDC Package Code	49035-962-28
Billing NDC	49035096228
Package	42 g in 1 BOTTLE (49035-962-28)
Marketing Start Date	2019-03-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c89 Details

Active ingredients

Homosalate 5.0%,

Octocrylene 10.0%,

Zinc Oxide 15.0%

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 product is swallowed, get medical help or contact a Poison Control 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

caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, tridecyl salicylate, lauryl laurate bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax

Label

INGREDIENTS AND APPEARANCE

EQUATE SUNSCREEN MINERAL BASED KIDS BROAD SPECTRUM SPF 50

homosalate , octocrylene, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-962
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCOA BUTTER (UNII: 512OYT1CRR)
LAURYL LAURATE (UNII: GPW77G0937)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
CERESIN (UNII: Q1LS2UJO3A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-962-28	42 g in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/26/2019

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2022

Document Id: c6b34a92-eff7-4d77-e053-2a95a90a683f

Set id: 0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c89

Version: 3

Effective Time: 20221030