SPL v4
SPL
SPL Set ID 2b41c17d-1394-0c2f-e063-6394a90a0c49
Route
TOPICAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (10 mg) Homosalate (73 mg) Octinoxate (74.9 mg) Avobenzone (30 mg)
Inactive Ingredients
Methyl Methacrylate Diethylhexyl Succinate Cyclopentasiloxane Pentylene Glycol Butylene Glycol Dextrin Palmitate (corn; 20000 Mw) Glycerin Aloe Ascorbyl Tetraisopalmitate Hydroxyproline Water Malva Sylvestris Flowering Top Rosemary Rosemary Oil Tocopherol Agar Bht Dipropylene Glycol Hydroxypropyl Methylcellulose Isohexadecane Octyldodecanol Peg-60 Glyceryl Isostearate Polysorbate 80 Sodium Acrylate Sorbitan Oleate Xanthan Gum Phenoxyethanol Ferrosoferric Oxide Methylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Homosalate 7.30% Octisalate 1.00% Avobenzone 3.00% Octinoxate 7.49%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

A sunscreen that protects skin from harmful environmental factors including UVA/UVB rays and dryness. Its lightweight, comfortable texture leaves skin hydrated, supple and radiant.

Uses

Helps prevent sunburn

Use as the final step in your morning skin care routine or before makeup. Apply generously and evenly before sun exposure. Reducing the amount of application will lower the level of protection significantly. For removal, use daily cleanser. Avoid contact with clothing and other textiles, as direct contact may stain. If clothing is stained, wash with detergent. Do not use chlorine bleach on stains.

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.

Section 51945-4

PRINCIPAL DISPLAY PANEL - 60 mL

DECORTÉ 

SUN SHELTER MULTI PROTECTION

Sunscreen

Broad Spectrum

SPF 50+

Lightweight

Hydrating Veil

e 60 mL NET WT. 2.1 OZ.

Warnings

For external use only

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply 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 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
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun.

Protects skin from UV rays and helps prevent dark spots.

Dermatologically tested.

Free from alcohol, parabens, and mineral oils.

Active Ingredients

Homosalate 7.30% Octisalate 1.00% Avobenzone 3.00% Octinoxate 7.49%

Inactive Ingredients

WATER/AQUA/EAU, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLHEXYL SUCCINATE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, ASCORBYL TETRAISOPALMITATE, HYDROLYZED COLLAGEN, HYDROXYPROLINE, MALVA SYLVESTRIS (MALLOW) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF WATER, TOCOPHEROL. ACRYLATES/DIMETHICONE COPOLYMER, AGAR, BHT, DIPROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ISOHEXADECANE, OCTYLDODECANOL, PEG-60 GLYCERYL ISOSTEARATE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, XANTHAN GUM, PHENOXYETHANOL, FRAGRANCE (PARFUM).

Keep Out of Reach of Children

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


Structured Label Content

Uses

Helps prevent sunburn

Use as the final step in your morning skin care routine or before makeup. Apply generously and evenly before sun exposure. Reducing the amount of application will lower the level of protection significantly. For removal, use daily cleanser. Avoid contact with clothing and other textiles, as direct contact may stain. If clothing is stained, wash with detergent. Do not use chlorine bleach on stains.

Description (34089-3)

A sunscreen that protects skin from harmful environmental factors including UVA/UVB rays and dryness. Its lightweight, comfortable texture leaves skin hydrated, supple and radiant.

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.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL - 60 mL

DECORTÉ 

SUN SHELTER MULTI PROTECTION

Sunscreen

Broad Spectrum

SPF 50+

Lightweight

Hydrating Veil

e 60 mL NET WT. 2.1 OZ.

Purpose

Sunscreen

Warnings

For external use only

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply 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 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
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Other Information

Protect this product from excessive heat and direct sun.

Protects skin from UV rays and helps prevent dark spots.

Dermatologically tested.

Free from alcohol, parabens, and mineral oils.

Active Ingredients

Homosalate 7.30% Octisalate 1.00% Avobenzone 3.00% Octinoxate 7.49%

Inactive Ingredients

WATER/AQUA/EAU, BUTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, DIETHYLHEXYL SUCCINATE, CYCLOPENTASILOXANE, PENTYLENE GLYCOL, DEXTRIN PALMITATE, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT, ASCORBYL TETRAISOPALMITATE, HYDROLYZED COLLAGEN, HYDROXYPROLINE, MALVA SYLVESTRIS (MALLOW) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF WATER, TOCOPHEROL. ACRYLATES/DIMETHICONE COPOLYMER, AGAR, BHT, DIPROPYLENE GLYCOL, HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER, ISOHEXADECANE, OCTYLDODECANOL, PEG-60 GLYCERYL ISOSTEARATE, POLYSORBATE 80, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SORBITAN OLEATE, XANTHAN GUM, PHENOXYETHANOL, FRAGRANCE (PARFUM).

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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