EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10- homosalate, octisalate spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
Wal-Mart Stores Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen • 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 • rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
49035-787-37

EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10- homosalate,

octisalate spray

Wal-Mart Stores Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Equate Tanning Sunscreen Dry Oil UVB Protection SPF 10 Spray

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 this product 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.

Equate Tanning Sunscreen Dry Oil UVB Protection SPF 10 Spray

EQUATE TANNING SUNSCREEN DRY OIL UVB PROTECTION SPF10

homosalate, octisalate spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-78 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

70 mg in 1 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

50 mg in 1 g

Wal-Mart Stores Inc

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

TRIDECYL SALICYLATE (UNII: AZQ0 8 K38 Z1)

ACRYLATE/ISO BUTYL METHACRYLATE/N-TERT-O CTYLACRYLAMIDE CO PO LYMER ( 7 50 0 0 MW) (UNII:

JU3XHR8 VWK)

MINERAL O IL (UNII: T5L8 T28 FGP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-78 7-37

156 g in 1 CAN; Type 0 : No t a Co mbinatio n Pro duct

0 4/18 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 4/18 /20 19

Labeler -

Wal-Mart Stores Inc (051957769)

Registrant -

FRUIT OF T HE EART H, INC. (079559467)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Fruit Of The Earth Research Labo rato ries, Inc.

0 0 8 19 3513

ma nufa c ture (49 0 35-78 7)

Revised: 12/2019

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