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

Purpose

Sunscreen

Description

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


Medication Information

Warnings

For external use only

Purpose

Sunscreen

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
Other Information

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

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>

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

Do Not Use

on damaged or broken skin

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 4.5%

OCTOCRYLENE 5%

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

Warnings

For external use only

Purpose

Sunscreen

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
Other Information (Other information)

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

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>

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

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

AVOBENZONE 3%

HOMOSALATE 7%

OCTISALATE 4.5%

OCTOCRYLENE 5%

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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