L'bel Divine Double Use Compact Spf 15 Gold Deluxe Edition

L'bel Divine Double Use Compact Spf 15 Gold Deluxe Edition
SPL v5
SPL
SPL Set ID b5e47c63-7e82-34fc-e053-2a95a90a767c
Route
TOPICAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (4.9 g) Titanium Dioxide (6.24 g) Octinoxate (3 g)
Inactive Ingredients
Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer .alpha.-tocopherol Acetate Ferric Oxide Red Geraniol Isomethyl-.alpha.-ionone .beta.-citronellol, (r)- Ferrosoferric Oxide Trimethylsiloxysilicate (m/q 0.6-0.8) Hydrogen Dimethicone (13 Cst) Limonene, (+)- Chlorphenesin Ferric Oxide Yellow Isostearyl Neopentanoate Hydroxycitronellal Phenoxyethanol Aluminum Oxide Magnesium Stearate Dimethicone Linalool, (+/-)- Mica Polymethylsilsesquioxane (11 Microns) Triethoxycaprylylsilane Caprylyl Glycol Ceramide Np

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-12

Description

Active ingredients Purpose Octinoxate 3.00% Sunscreen Titanium Dioxide 6.24% Sunscreen Zinc Oxide 4.90 % Sunscreen


Medication Information

Warnings and Precautions

Warnings: Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under 6 months of age: Ask a doctor

Description

Active ingredients Purpose Octinoxate 3.00% Sunscreen Titanium Dioxide 6.24% Sunscreen Zinc Oxide 4.90 % Sunscreen

Section 50565-1

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

Section 51727-6

Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

Section 55105-1

Uses:

Helps prevent Sunburn

Section 55106-9

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

Section 60561-8

Other information:

Protect the product in this container from excessive heat and direct sun

Product Labeling Obscure 8 9


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions:

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Children under 6 months of age: Ask a doctor

Warnings and Precautions (34071-1)

Warnings: Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 swallowed, get medical help, or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients: Mica, polymethylsilsesquioxane, hdi/trimethylol hexyllactone crosspolymer, dimethicone, magnesium stearate, trimethylsiloxysilicate, isostearyl neopentanoate, hydrogen dimethicone, tocopheryl acetate, phenoxyethanol, alumina, triethoxycaprylylsilane, fragrance, caprylyl glycol, ceramide np, chlorphenesin, linalool, hydroxycitronellal, citronellol, geraniol, limonene, alpha-isomethyl ionone, May contain: Iron oxides, titanium dioxide

Section 55105-1 (55105-1)

Uses:

Helps prevent Sunburn

Section 55106-9 (55106-9)

Active ingredients Purpose

Octinoxate 3.00% Sunscreen

Titanium Dioxide 6.24% Sunscreen

Zinc Oxide 4.90 % Sunscreen

Section 60561-8 (60561-8)

Other information:

Protect the product in this container from excessive heat and direct sun

Product Labeling Obscure 8 9 (Product Labeling Obscure 8-9)


Advanced Ingredient Data


Raw Label Data

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