Mineral Unseen Sunscreen Spf 40

Mineral Unseen Sunscreen Spf 40
SPL v2
SPL
SPL Set ID 08671d39-3be2-d666-e063-6294a90a6207
Route
TOPICAL
Published
Effective Date 2023-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (17.68 g) Titanium Dioxide (1.33 g)
Inactive Ingredients
Dimethicone C9-12 Alkane Hedychium Coronarium Root Tocopherol Glycerin Water Methyl Dihydroabietate Coco-caprylate/caprate Stearic Acid Polyhydroxystearic Acid (2300 Mw) Silicon Dioxide Ethylhexylglycerin Medium-chain Triglycerides Propanediol Schisandra Chinensis Fruit Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-23

Description

Active Ingredients: Titanium Dioxide 1.33%, Zinc Oxide 17.68%


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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX 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 protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Description

Active Ingredients: Titanium Dioxide 1.33%, Zinc Oxide 17.68%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6

Inactive Ingredients: DIMETHICONE, DIMETHICONE CROSSPOLLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYL DIHYDROABIETATE, POLYHYDROXYSTEARIC ACID, C9-12 ALKANE, GLYCERIN, ETHYLHEXYLGLYCERIN, WATER (AQUA), COCO-CAPRYLATE/CAPRATE, SILICA, STEARIC ACID, HEDYCHIUM CORONARIUM ROOT EXTRACT, PROPANEDIOL, SCHIZANDRA CHINENSIS FRUIT EXTRACT, TOCOPHEROL

Section 51945-4

Mineral Unseen Sunscreen SPF 40

Broad Spectrum Sunscreen

1.7 fl. oz. / 50 ml

Mineral Unseen Sunscreen SPF 40

15 mL

Mineral Unseen Sunscreen SPF 40

10 ml

Mineral Unseen Sunscreen SPF 40

1.5 ml

Section 55105-1

Helps prevent sunburn

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

Section 55106-9

Active Ingredients: Titanium Dioxide 1.33%, Zinc Oxide 17.68%


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX 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 protection measures including:

Limit time in the sun, especially from 10 a.m.- 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

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

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6 (51727-6)

Inactive Ingredients: DIMETHICONE, DIMETHICONE CROSSPOLLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, METHYL DIHYDROABIETATE, POLYHYDROXYSTEARIC ACID, C9-12 ALKANE, GLYCERIN, ETHYLHEXYLGLYCERIN, WATER (AQUA), COCO-CAPRYLATE/CAPRATE, SILICA, STEARIC ACID, HEDYCHIUM CORONARIUM ROOT EXTRACT, PROPANEDIOL, SCHIZANDRA CHINENSIS FRUIT EXTRACT, TOCOPHEROL

Section 51945-4 (51945-4)

Mineral Unseen Sunscreen SPF 40

Broad Spectrum Sunscreen

1.7 fl. oz. / 50 ml

Mineral Unseen Sunscreen SPF 40

15 mL

Mineral Unseen Sunscreen SPF 40

10 ml

Mineral Unseen Sunscreen SPF 40

1.5 ml

Section 55105-1 (55105-1)

Helps prevent sunburn

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

Section 55106-9 (55106-9)

Active Ingredients: Titanium Dioxide 1.33%, Zinc Oxide 17.68%


Advanced Ingredient Data


Raw Label Data

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