Dramatically Different Moisturizing Lotion+ Broad Spectrum Spf35

Dramatically Different Moisturizing Lotion+ Broad Spectrum Spf35
SPL v3
SPL
SPL Set ID 316bf6f8-7d30-2560-e063-6294a90afb8a
Route
TOPICAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (70 mg) Octisalate (45 mg) Avobenzone (30 mg) Octocrylene (50 mg)
Inactive Ingredients
Butylene Glycol Potassium Cetyl Phosphate Edetate Disodium Anhydrous Potassium Sorbate Sodium Hyaluronate Fd&c Yellow No. 5 Peg-100 Stearate Silica D&c Red No. 33 Phenyl Trimethicone Hydrogenated Soybean Lecithin Cetearyl Alcohol Hexylene Glycol Tromethamine Phenoxyethanol Dextrin Palmitate (corn; 20000 Mw) Carbomer Water Glycerin Butyloctyl Salicylate Biosaccharide Gum-1 Caprylyl Glycol Triacontanyl Pvp Stearyl Alcohol Dehydroxanthan Gum Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31

Description

AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 4.5% OCTOCRYLENE 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 4.5% OCTOCRYLENE 5%

Use

helps prevent sunburn

Section 51945-4

CLINIQUE

dramatically different

moisturizing loition +

broad spectrum

SPF35

VERY DRY TO DRY COMBINATION

2.5FL.OZ.LIQ./75 ml

Warnings

For external use only

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 value 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Do Not Use

on damaged or broken skin

Other Information

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

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 4.5%

OCTOCRYLENE 5%

Inactive Ingredients

water\aqua\eau,glycerin,butylene glycol,phenyl trimethicone,butyloctyl salicylate,peg-100 stearate,silica,silica silylate,hydrogenated lecithin,dextrin palmitate,sodium hyaluronate,biosaccharide gum-1,caprylyl glycol,cetearyl alcohol,potassium cetyl phosphate,hexylene glycol,tromethamine,triacontanyl pvp,carbomer,stearyl alcohol,dehydroxanthan gum,disodium edta,phenoxyethanol,potassium sorbate,red 33 (ci 17200),yellow 5 (ci 19140),yellow 6 (ci 15985) <iln53527>

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

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


Structured Label Content

Use

helps prevent sunburn

Section 51945-4 (51945-4)

CLINIQUE

dramatically different

moisturizing loition +

broad spectrum

SPF35

VERY DRY TO DRY COMBINATION

2.5FL.OZ.LIQ./75 ml

Purpose

Sunscreen

Warnings

For external use only

Directions
  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 value 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-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)

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

Active Ingredients (Active ingredients)

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 4.5%

OCTOCRYLENE 5%

Inactive Ingredients

water\aqua\eau,glycerin,butylene glycol,phenyl trimethicone,butyloctyl salicylate,peg-100 stearate,silica,silica silylate,hydrogenated lecithin,dextrin palmitate,sodium hyaluronate,biosaccharide gum-1,caprylyl glycol,cetearyl alcohol,potassium cetyl phosphate,hexylene glycol,tromethamine,triacontanyl pvp,carbomer,stearyl alcohol,dehydroxanthan gum,disodium edta,phenoxyethanol,potassium sorbate,red 33 (ci 17200),yellow 5 (ci 19140),yellow 6 (ci 15985) <iln53527>

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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