spf 50 lotion

spf 50 lotion
SPL v3
SPL
SPL Set ID 26f85758-820f-3f73-e063-6294a90a289d
Route
topical
Published
Effective Date 2024-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (0.144 g)
Inactive Ingredients
cellulose gum arachidyl glucoside arachidyl alcohol polyhydroxystearic acid (2300 mw) butyloctyl salicylate sodium hyaluronate sodium stearoyl glutamate methyl dihydroabietate butyrospermum parkii (shea) butter tocopherol beta-sitosterol cetearyl alcohol citric acid ethylhexylglycerin cocos nucifera (coconut) oil microcrystalline cellulose squalene theobroma cacao (cocoa) seed butter sodium gluconate bisabolol helianthus annuus (sunflower) seed oil coco-glucoside behenyl alcohol capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) water phenoxyethanol diheptyl succinate cetyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-11-01

Description

Zinc Oxide 19.6%


Medication Information

Warnings and Precautions

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

Active Ingredient

Zinc Oxide 19.6%

Uses

Helps prevent sunburn. If used as directed with other sun protection measured (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

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 • 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 protecting measures including • Limit time in the sun, especially from 1Oam - 2pm Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months Ask a doctor

Description

Zinc Oxide 19.6%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, , Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water

Section 51945-4

Section 53413-1

212-627-0377 M-F 9am to 5pm EST

Section 55105-1

Sunscreen

Section 60561-8

Protect this product from excessive hear and direct sun


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Zinc Oxide 19.6%

Uses

Helps prevent sunburn. If used as directed with other sun protection measured (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Directions

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 • 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 protecting measures including • Limit time in the sun, especially from 1Oam - 2pm Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months Ask a doctor

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center immediately

Section 51727-6 (51727-6)

Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, , Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) OiI, Diheptyl Succinate, Ethylhexlglycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Phenoxyethanol, Polyhydroxystearic Acid, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

212-627-0377 M-F 9am to 5pm EST

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)

Protect this product from excessive hear and direct sun


Advanced Ingredient Data


Raw Label Data

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