Rocky Mountain Spf 30 Lotion

Rocky Mountain Spf 30 Lotion
SPL v1
SPL
SPL Set ID 81a53bff-c4e9-423f-e053-2991aa0a5d79
Route
TOPICAL
Published
Effective Date 2019-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.8 g) Octocrylene (5 g) Homosalate (7 g)
Inactive Ingredients
Sorbitan Isostearate Vinylpyrrolidone/eicosene Copolymer Butyloctyl Salicylate Carbomer 934 Triethanolamine 2-cyclohexyl-4,6-dinitrophenolate Aluminum Starch Octenylsuccinate .alpha.-(.alpha.-aminopropyl)benzyl Alcohol Hydrochloride, Erythro-(+/-)- Tocopherol Methylparaben Polyglyceryl-3 Distearate Isopropylparaben Edetate Disodium Anhydrous Water Dimethicone 500 Stearic Acid D7 Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-11

Description

Avobenzone - 1.8% Homosalate - 7.0% Octocrylene - 5.0%


Medication Information

Warnings and Precautions

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

Indications and Usage

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

Dosage and Administration

Apply liberally 15 minutews befor sun exposure

Reaaply:

- fter 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

Description

Avobenzone - 1.8% Homosalate - 7.0% Octocrylene - 5.0%

Uses



Avobenzone - 1.8% ................. Sunscreen

Homosalate - 7.0% .................. Sunscreen

Octocrylene - 5.0% ...................Sunscreen

Section 51727-6

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

Dimethicone

Disodium EDTA

Methylparaben

Polyglyceryl-3 Distearate

Propylparaben

Sorbitan Isostearate

Sorbitol

Stearic Acid

Tocopherol

Triethanolamine

VP/Eicosene Copolymer

Water

Section 51945-4

Warnings



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnmings



Stop use and ask a doctor if rash occurs.

Active Ingredients



Avobenzone - 1.8%

Homosalate - 7.0%

Octocrylene - 5.0%

When Using This Product

When using this product:

• keep out of eyes. Rinse with water to remove.

• Keep away from face to avoid breathing it.


Structured Label Content

Uses



Avobenzone - 1.8% ................. Sunscreen

Homosalate - 7.0% .................. Sunscreen

Octocrylene - 5.0% ...................Sunscreen

Indications and Usage (34067-9)

Helps prevent sunburn

Higher SPF gives more sunburn protection

If used as directed with other sun protection measures, decreases the reisk of skin cancer and early skim agingcaused by the s

Dosage and Administration (34068-7)

Apply liberally 15 minutews befor sun exposure

Reaaply:

- fter 80 monutes of swimming or sweating

- immediatly after towel drying

- at least every 2 hours

Warnings and Precautions (34071-1)

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

Section 51727-6 (51727-6)

Aluminum Starch Octenylsuccinate

Benzyl Alcohol

Butyloctyl Salicylate

Carbomer

Dimethicone

Disodium EDTA

Methylparaben

Polyglyceryl-3 Distearate

Propylparaben

Sorbitan Isostearate

Sorbitol

Stearic Acid

Tocopherol

Triethanolamine

VP/Eicosene Copolymer

Water

Section 51945-4 (51945-4)

Warnings



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnmings



Stop use and ask a doctor if rash occurs.

Active Ingredients



Avobenzone - 1.8%

Homosalate - 7.0%

Octocrylene - 5.0%

When Using This Product (When using this product)

When using this product:

• keep out of eyes. Rinse with water to remove.

• Keep away from face to avoid breathing it.


Advanced Ingredient Data


Raw Label Data

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