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NDC 49035-0787-37 EQUATE Tanning Sunscreen Dry oil UVB Protection SPF10 70; 50 mg/g; mg/g Details

EQUATE Tanning Sunscreen Dry oil UVB Protection SPF10 70; 50 mg/g; mg/g

EQUATE Tanning Sunscreen Dry oil UVB Protection SPF10 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is HOMOSALATE; OCTISALATE.

Product Information

NDC	49035-0787
Product ID	49035-787_ec36d6a7-f2e0-24e5-e053-2a95a90aa11a
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 Tanning Sunscreen Dry oil UVB Protection SPF10
Proprietary Name Suffix	n/a
Non-Proprietary Name	Homosalate, Octisalate
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	70; 50
Active Ingredient Units	mg/g; mg/g
Substance Name	HOMOSALATE; OCTISALATE
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 49035-0787-37 (49035078737)

Pricing Information	N/A
NDC Package Code	49035-787-37
Billing NDC	49035078737
Package	156 g in 1 CAN (49035-787-37)
Marketing Start Date	2019-04-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0c256aba-453a-4171-a1a5-e50c22649982 Details

Active ingredients

Homosalate 7.0%

Octisalate 5.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn

• Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early signs of aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging

Warnings

For external use only

FLAMMABLE:

• do not use near heat, flame or while smoking

• avoid long term storage above 104°F (40°C)

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

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

alcohol denat., tridecyl salicylate, acrylates/octylacrylamide copolymer, fragrance, mineral oil.

Label

INGREDIENTS AND APPEARANCE

EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10

homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-787
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-787-37	156 g in 1 CAN; Type 0: Not a Combination Product	04/18/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/18/2019

Labeler - Wal-Mart Stores Inc (051957769)

Revised: 10/2022

Document Id: ec36d6a7-f2e0-24e5-e053-2a95a90aa11a

Set id: 0c256aba-453a-4171-a1a5-e50c22649982

Version: 3

Effective Time: 20221029