Celazome®

Drug Facts

Composition & Product

Active Ingredients

Oxybenzone (50 mg) Octinoxate (75 mg) Octisalate Homosalate

Inactive Ingredients

Water Dioctyl Maleate Alcohol Sorbitol Diethanolamine Cetyl Phosphate Aloe Vera Leaf .alpha.-tocopherol Acetate Dimethicone, Unspecified Cetyl Alcohol Trolamine Propylparaben Methylparaben

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-10-01

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

helps prevent sunburn

Section 42229-5

Drug Facts

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 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Directions

apply liberally 15 minutes before sun exposure
reapply:
- after 80 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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Active Ingredients

Benzophenone-3 5.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate 5.0%

Homosalate 5.0%

Inactive Ingredients

purifed water, sorbitol, dicaprylyl maleate, alcohol, potassium cetyl phosphate, lecithin, cetyl alcohol, dimethicone, tocopheryl acetate, aloe barbadensis leaf juice, carbomer, methylparaben, propylparaben, triethanolamine

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.

Principal Display Panel 113 G Bottle Carton

celazome ^®

clinical skin care

Moisturizing Sunscreen

Clinical Skin Care with

Lyphazome^® Technology

SPF 30 ACTIVE

SPORT

WATER RESISTANT

(80 MINUTES)

4 OZ (113 g)

Structured Label Content

Uses

helps prevent sunburn

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Directions

apply liberally 15 minutes before sun exposure
reapply:
- after 80 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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Active Ingredients (Active ingredients)

Benzophenone-3 5.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate 5.0%

Homosalate 5.0%

Inactive Ingredients (Inactive ingredients)

purifed water, sorbitol, dicaprylyl maleate, alcohol, potassium cetyl phosphate, lecithin, cetyl alcohol, dimethicone, tocopheryl acetate, aloe barbadensis leaf juice, carbomer, methylparaben, propylparaben, triethanolamine

Skin Cancer/skin Aging Alert (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.

Principal Display Panel 113 G Bottle Carton (PRINCIPAL DISPLAY PANEL - 113 g Bottle Carton)

celazome ^®

clinical skin care

Moisturizing Sunscreen

Clinical Skin Care with

Lyphazome^® Technology

SPF 30 ACTIVE

SPORT

WATER RESISTANT

(80 MINUTES)

4 OZ (113 g)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps prevent sunburn", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "Purpose": "Sunscreen", "Directions": "apply liberally 15 minutes before sun exposure reapply: after 80 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 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-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor", "Active ingredients": "Benzophenone-3 5.0% Ethylhexyl Methoxycinnamate 7.5% Ethylhexyl Salicylate 5.0% Homosalate 5.0%", "Inactive ingredients": "purifed water, sorbitol, dicaprylyl maleate, alcohol, potassium cetyl phosphate, lecithin, cetyl alcohol, dimethicone, tocopheryl acetate, aloe barbadensis leaf juice, carbomer, methylparaben, propylparaben, triethanolamine", "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.", "PRINCIPAL DISPLAY PANEL - 113 g Bottle Carton": "celazome ® clinical skin care Moisturizing Sunscreen Clinical Skin Care with Lyphazome ® Technology SPF 30 ACTIVE SPORT WATER RESISTANT (80 MINUTES) 4 OZ (113 g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information