natural mineral sunscreen spf 30

natural mineral sunscreen spf 30
SPL v1
SPL
SPL Set ID 6ce3072e-985c-42db-b711-b290b9d0ab22
Route
topical
Published
Effective Date 2012-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (12.1 g)
Inactive Ingredients
dicaprylyl carbonate polyglyceryl-3 diisostearate stearic acid aluminum hydroxide medium-chain triglycerides coco-caprylate coco-caprylate/caprate alcohol argan oil caprylyl/capryl oligoglucoside coconut oil gardenia taitensis flower zanthoxylum armatum var. armatum fruit oleyl alcohol linalool, (+/-)- limonene, (+)- p-methyl anisole benzyl benzoate methyl benzoate benzyl salicylate farnesol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2012-04-26

Description

Drug Facts Active ingredients                                                                                   Purpose Titanium dioxide (12,1%) ........................................................................Sunscreen Use • Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions • Apply generously and evenly to all areas 15 minutes before sun exposure • Spray on hands to apply to face • Reapply at frequent intervals and after swimming, sweating or towel drying • Ask a doctor before use on children under six months of age Other information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Inactive ingredients DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE, COCO-CAPRYLATE/CAPRATE, ALCOHOL*, ARGANIA SPINOSA KERNEL OIL*, ALUMINIUM HYDROXIDE, STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, PARFUM (FRAGRANCE), COCOS NUCIFERA (COCONUT) OIL, GARDENIA TAHITENSIS FLOWER, OLEYL ALCOHOL, ZANTHOXYLUM ALATUM FRUIT EXTRACT. *Ingredients from organic farming


Medication Information

Active Ingredient

Drug Facts

Active ingredients                                                                                   Purpose

Titanium dioxide (12,1%) ........................................................................Sunscreen

Use

• Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides

high protection against sunburn

Warnings

For external use only. When using this product keep out of eyes. Rinse with water

to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep

out of the reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

• Apply generously and evenly to all areas 15 minutes before sun exposure • Spray on

hands to apply to face • Reapply at frequent intervals and after swimming, sweating

or towel drying • Ask a doctor before use on children under six months of age

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens

may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE,

COCO-CAPRYLATE/CAPRATE, ALCOHOL*, ARGANIA SPINOSA KERNEL OIL*, ALUMINIUM HYDROXIDE,

STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, PARFUM (FRAGRANCE), COCOS NUCIFERA

(COCONUT) OIL, GARDENIA TAHITENSIS FLOWER, OLEYL ALCOHOL, ZANTHOXYLUM ALATUM FRUIT

EXTRACT. *Ingredients from organic farming





Description

Drug Facts Active ingredients                                                                                   Purpose Titanium dioxide (12,1%) ........................................................................Sunscreen Use • Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Directions • Apply generously and evenly to all areas 15 minutes before sun exposure • Spray on hands to apply to face • Reapply at frequent intervals and after swimming, sweating or towel drying • Ask a doctor before use on children under six months of age Other information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Inactive ingredients DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE, COCO-CAPRYLATE/CAPRATE, ALCOHOL*, ARGANIA SPINOSA KERNEL OIL*, ALUMINIUM HYDROXIDE, STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, PARFUM (FRAGRANCE), COCOS NUCIFERA (COCONUT) OIL, GARDENIA TAHITENSIS FLOWER, OLEYL ALCOHOL, ZANTHOXYLUM ALATUM FRUIT EXTRACT. *Ingredients from organic farming

Section 51945-4


Structured Label Content

Active Ingredient (55106-9)

Drug Facts

Active ingredients                                                                                   Purpose

Titanium dioxide (12,1%) ........................................................................Sunscreen

Use

• Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides

high protection against sunburn

Warnings

For external use only. When using this product keep out of eyes. Rinse with water

to remove. Stop use and ask a doctor if rash or irritation develops and lasts. Keep

out of the reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

• Apply generously and evenly to all areas 15 minutes before sun exposure • Spray on

hands to apply to face • Reapply at frequent intervals and after swimming, sweating

or towel drying • Ask a doctor before use on children under six months of age

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens

may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

DICAPRYLYL CARBONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE,

COCO-CAPRYLATE/CAPRATE, ALCOHOL*, ARGANIA SPINOSA KERNEL OIL*, ALUMINIUM HYDROXIDE,

STEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, PARFUM (FRAGRANCE), COCOS NUCIFERA

(COCONUT) OIL, GARDENIA TAHITENSIS FLOWER, OLEYL ALCOHOL, ZANTHOXYLUM ALATUM FRUIT

EXTRACT. *Ingredients from organic farming





Section 51945-4 (51945-4)


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