SPL v2
SPL
SPL Set ID 0acc5a23-a4db-4aba-8936-b78b1c638c28
Route
TOPICAL
Published
Effective Date 2018-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.67 g) Octinoxate (1.95 g) Zinc Cation (0.27 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-10-01

Description

Active ingredients: Titanium Dioxide 8.90%, Ethylhexyl Methoxycinnamate 6.50%, Zinc Oxide 0.90%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses: - Ultralight, pink toned beauty balm to protect, tint, and moisturize skin - Features SPF 35 PA++ sun protection

Directions: Apply moderate amount on entire face after basic skin care.

Warnings

Warning: 1) For external use only. 2) Consult a dermatologist if the first sign occurs like red spot, swelling, itching, or any allergic reactions. 3) Avoid direct contact with eyes. 4) If contact occurs, flush thoroughly with water. 5) If swallowed, get medical help or contact a Poison Control Center right away. 6) Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.

Active Ingredient

Active ingredients: Titanium Dioxide 8.90%, Ethylhexyl Methoxycinnamate 6.50%, Zinc Oxide 0.90%

Inactive Ingredient

Inactive ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Dipropylene Glycol, Hexyl Laurate, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Bentonite, Chrysanthellum Morifolium Flower Extract, Magnesium Sulfate, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, Centella Asiatica Extract, Silica, CI 77492, CI 77491, CI 77499, Sorbitan Isostearate, Tocopheryl Acetate, Allantoin, Ceramide 3, Methylparaben, Propylparaben, Disodium EDTA, Fragrance

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warning: 1) For external use only. 2) Consult a dermatologist if the first sign occurs like red spot, swelling, itching, or any allergic reactions. 3) Avoid direct contact with eyes. 4) If contact occurs, flush thoroughly with water. 5) If swallowed, get medical help or contact a Poison Control Center right away. 6) Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Storage and cautions for handling: 1) Keep out of reach of children. 2) Keep away from high or low temperature and direct sunlight.

Description (DESCRIPTION)

Uses: - Ultralight, pink toned beauty balm to protect, tint, and moisturize skin - Features SPF 35 PA++ sun protection

Directions: Apply moderate amount on entire face after basic skin care.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 8.90%, Ethylhexyl Methoxycinnamate 6.50%, Zinc Oxide 0.90%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, Dipropylene Glycol, Hexyl Laurate, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Bentonite, Chrysanthellum Morifolium Flower Extract, Magnesium Sulfate, Althaea Rosea Flower Extract, Aloe Barbadensis Leaf Extract, Butyrospermum Parkii (Shea) Butter, Centella Asiatica Extract, Silica, CI 77492, CI 77491, CI 77499, Sorbitan Isostearate, Tocopheryl Acetate, Allantoin, Ceramide 3, Methylparaben, Propylparaben, Disodium EDTA, Fragrance

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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