EQUATE SPF 70 ULTRA SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

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

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Active ingredient:
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%
Available from:
Wal-Mart Stores Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun Do not use • on damaged or broken skin. Stop use and ask a doctor if • rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
49035-760-12

EQUATE SPF 70 ULTRA SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene,

oxybenzone lotion

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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Walmart Equate SPF 70 Ultra Sunscreen Lotion – Drug Facts

Walmart Equate SPF 70 Ultra Sunscreen Lotion – Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpos e

Sunscreen

Us es

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin

cancer and early 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

Water, butylene glycol, microcrystalline cellulose, glyceryl stearate, behenyl alcohol, butylated PVP,

benzyl alcohol, palmitic acid, myristyl alcohol, caprylic/capric triglyceride, stearic acid, lauryl

alcohol, cetyl alcohol, sodium ascorbyl phosphate, tocopherol (vitamin E), lecithin, cellulose gum,

chlorphenesin, disodium EDTA, fragrance.

Walmart Equate SPF 70 Ultra Sunscreen Lotion

236 mL

NDC 49035-760-12

EQUATE SPF 70 ULTRA SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:49 0 35-76 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

6 0 mg in 1 mL

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

HOMOSALATE

150 mg in 1 mL

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

OCTISALATE

50 mg in 1 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

10 0 mg in 1 mL

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

30 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PALMITIC ACID (UNII: 2V16 EO9 5H1)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

N-VINYLPYRRO LIDINO NE (UNII: 76 H9 G8 1541)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DO CO SANO L (UNII: 9 G1OE216 XY)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

LAURYL ALCO HO L (UNII: 178 A9 6 NLP2)

MYRISTYL ALCO HO L (UNII: V420 34O9 PU)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:49 0 35-76 0 -12

236 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 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 8 /0 2/20 19

Labeler -

Wal-Mart Stores Inc (051957769)

Registrant -

Fruit Of T he Earth, Inc. (079559467)

Wal-Mart Stores Inc

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 35-76 0 )

Revised: 8/2019

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