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

SPL v4

SPL

SPL Set ID b3747373-ef67-89ff-e053-2995a90afcde

Route

TOPICAL

Published

Effective Date 2020-11-23

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

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

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 Claire 4

Product Labeling Medium 5

Product Labeling Medium 6

Product Labeling Medium 7

Product Labeling Claire 1 2 3

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)

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)

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 Claire 4

Product Labeling Medium 5

Product Labeling Medium 6

Product Labeling Medium 7

Product Labeling Claire 1 2 3 (Product Labeling Claire 1-2-3)

Advanced Ingredient Data

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{"34067-9": "Stop use and ask a doctor if rash occurs.", "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", "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.", "50565-1": "Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.", "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", "55105-1": "Uses: Helps prevent Sunburn", "55106-9": "Active ingredients Purpose Octinoxate 3.00% Sunscreen Titanium Dioxide 6.24% Sunscreen Zinc Oxide 4.90 % Sunscreen", "60561-8": "Other information: Protect the product in this container from excessive heat and direct sun"}

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Source: dailymed · Ingested: 2026-02-15T12:06:21.871562 · Updated: 2026-03-14T23:09:05.302478