essence

essence
SPL v1
SPL
SPL Set ID 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0
Route
topical
Published
Effective Date 2025-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (25 g)
Inactive Ingredients
water alkyl (c12-15) benzoate dibutyl adipate butyloctyl salicylate medium-chain triglycerides polyglyceryl-2 dipolyhydroxystearate propanediol polyglyceryl-3 diisostearate triethoxycaprylylsilane 1,2-hexanediol c15-19 alkane glycerin polyhydroxystearic acid (2300 mw) sea salt hydroxyacetophenone levomenol stearalkonium hectorite magnesium sulfate, unspecified form allantoin hydrogenated palm oil tocopherol hydrogenated rapeseed oil soybean oil .beta.-sitosterol ethylhexylglycerin propylene carbonate squalene

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-10

Purpose

Sunscreen

Description

Zinc Oxide 25%


Medication Information

Warnings

• For external use only • Do not use on damaged or broken skin.

When using this product • avoid contact with eyes. If contact occurs, rinse thoroughly with water to remove.

Stop use and ask a doctor • if rash occurs.

Uses

• Helps to prevent sunburn.

• If used as directed with other sun protective measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure.

Reapply: • after 40 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 protection measures including: • Limit time in sun from 10 a.m.- 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. • Children under 6 months: Ask a doctor.

Inactive Ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Dibutyl Adipate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Propanediol, Polyglyceryl-3 Diisostearate, Triethoxycaprylylsilane, 1,2-Hexanediol, C15-19 Alkane, Glycerin, Polyhydroxystearic Acid, Maris Sal (Sea Salt), Hydroxyacetophenone, Bisabolol, Stearalkonium Hectorite, Magnesium Sulfate, Allantoin, Hydrogenated Palm Oil, Tocopherol, Hydrogenated Rapeseed Oil, Glycine Soja (Soybean) Oil, Beta-Sitosterol, Ethylhexylglycerin, Propylene Carbonate, Squalene.

Description

Zinc Oxide 25%

Section 42229-5

TENDER LOVING CARE

DERMATOLOGICALLY TESTED

FOR SENSITIVE SKIN

For All Skin Types

Experience superior sun protection with a silky-smooth touch. This fragrance- free lotion is powered exclusively by Zinc Oxide, providing a safe and effective mineral shield-free of chemical UV filters.

Unlike traditional mineral sunscreens, its creamy texture is effortlessly absorbed with several massage motions without leaving a heavy white cast on the skin making it perfect for daily wear-even under makeup.

Infused with a soothing blend of Bisabolol and Allantoin, plus potent antioxidants such as Vitamin E (Toco-pherol) and Hydroxyacetophenone, this formula helps prevent free radical damage essential during sun exposure.

Replenishing seed oils and phytosterols reinforce the skin‘s natural barrier, while Dead Sea minerals enhance long-lasting moisture retention. The unique water- in-oil emulsion resists wash-off, locking in softness and elasticity for all-day comfort.

How to Use: Apply generously to face and neck before sun exposure. Gently massage in any initial white tint, which disappears within seconds, leaving skin smooth and protected. Reapply as needed based on individual sun sensitivity.

Distributed by:

Catherine Hinds Institute


300 Wildwood Ave. Woburn,

MA 01801

[email protected] 

Tel.: (781) 935-3344

Imported by: Anna Lotan USA Inc. 

16 Wheeling Ave, Woburn, MA 01801

Section 50565-1

Keep out of reach of children • if product is swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredients

Zinc Oxide 25%

Questions Or Comments?

[email protected] 

Tel.: (781) 281 0954


Structured Label Content

Warnings

• For external use only • Do not use on damaged or broken skin.

When using this product • avoid contact with eyes. If contact occurs, rinse thoroughly with water to remove.

Stop use and ask a doctor • if rash occurs.

Uses

• Helps to prevent sunburn.

• If used as directed with other sun protective measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure.

Reapply: • after 40 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 protection measures including: • Limit time in sun from 10 a.m.- 2 p.m. • Wear long-sleeve shirts, pants, hats and sunglasses. • Children under 6 months: Ask a doctor.

Inactive Ingredients

Aqua (Water), C12-15 Alkyl Benzoate, Dibutyl Adipate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Propanediol, Polyglyceryl-3 Diisostearate, Triethoxycaprylylsilane, 1,2-Hexanediol, C15-19 Alkane, Glycerin, Polyhydroxystearic Acid, Maris Sal (Sea Salt), Hydroxyacetophenone, Bisabolol, Stearalkonium Hectorite, Magnesium Sulfate, Allantoin, Hydrogenated Palm Oil, Tocopherol, Hydrogenated Rapeseed Oil, Glycine Soja (Soybean) Oil, Beta-Sitosterol, Ethylhexylglycerin, Propylene Carbonate, Squalene.

Section 42229-5 (42229-5)

TENDER LOVING CARE

DERMATOLOGICALLY TESTED

FOR SENSITIVE SKIN

For All Skin Types

Experience superior sun protection with a silky-smooth touch. This fragrance- free lotion is powered exclusively by Zinc Oxide, providing a safe and effective mineral shield-free of chemical UV filters.

Unlike traditional mineral sunscreens, its creamy texture is effortlessly absorbed with several massage motions without leaving a heavy white cast on the skin making it perfect for daily wear-even under makeup.

Infused with a soothing blend of Bisabolol and Allantoin, plus potent antioxidants such as Vitamin E (Toco-pherol) and Hydroxyacetophenone, this formula helps prevent free radical damage essential during sun exposure.

Replenishing seed oils and phytosterols reinforce the skin‘s natural barrier, while Dead Sea minerals enhance long-lasting moisture retention. The unique water- in-oil emulsion resists wash-off, locking in softness and elasticity for all-day comfort.

How to Use: Apply generously to face and neck before sun exposure. Gently massage in any initial white tint, which disappears within seconds, leaving skin smooth and protected. Reapply as needed based on individual sun sensitivity.

Distributed by:

Catherine Hinds Institute


300 Wildwood Ave. Woburn,

MA 01801

[email protected] 

Tel.: (781) 935-3344

Imported by: Anna Lotan USA Inc. 

16 Wheeling Ave, Woburn, MA 01801

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.

Packaging

Drug Facts

Active Ingredients

Zinc Oxide 25%

Questions Or Comments? (Questions or Comments?)

[email protected] 

Tel.: (781) 281 0954


Advanced Ingredient Data


Raw Label Data

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