Celazome®

Celazome®
SPL v3
SPL
SPL Set ID 99fb90ca-6527-459b-8af2-627ea9abe11b
Route
TOPICAL
Published
Effective Date 2018-11-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (60 mg) Octinoxate (75 mg) Octisalate (50 mg) 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

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • 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 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.

Warnings

For external use only.

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 6.0%

Butyl Methoxydibenzoylmethane 3.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate 5.0%

Homosalate 6.0%

Inactive Ingredients

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

Principal Display Panel 113 G Bottle Carton

celazome®

clinical skin care

DNArescue

Moisturizing Sunscreen

Clinical Skin Care with

Lyphazome® Nanotechnology

SPF 29 ACTIVE

BROAD SPECTRUM

WATER RESISTANT

(80 MINUTES)

4 OZ (113 g)


Structured Label Content

Uses
  • 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 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

Warnings

For external use only.

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 6.0%

Butyl Methoxydibenzoylmethane 3.0%

Ethylhexyl Methoxycinnamate 7.5%

Ethylhexyl Salicylate 5.0%

Homosalate 6.0%

Inactive Ingredients (Inactive ingredients)

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

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

celazome®

clinical skin care

DNArescue

Moisturizing Sunscreen

Clinical Skin Care with

Lyphazome® Nanotechnology

SPF 29 ACTIVE

BROAD SPECTRUM

WATER RESISTANT

(80 MINUTES)

4 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)