Anna Lotan Ultra-gentle Sheer Mineral Protection Uva/uvb Spf50

Anna Lotan Ultra-gentle Sheer Mineral Protection Uva/uvb Spf50
SPL v3
SPL
SPL Set ID ab3c5e1e-3e4e-4b0c-9245-f4a3a62e053b
Route
TOPICAL
Published
Effective Date 2025-11-03
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 Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 25%

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.

Section 42229-5

SUN Select

For all skin types

TENDER LOVING CARE

DERMATOLOGICALLY TESTED

FOR SENSITIVE SKIN

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 textureis 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 Bisabololand Allantoin, plus potent antioxidantssuch as Vitamin E (Tocopherol)and Hydroxyacetophenone, this formula helps prevent free radical damage essential during sun exposure.

Replenishing seed oilsand phytosterolsreinforce the skin's natural barrier, while Dead Seaminerals enhance long-lasting moisture retention. The unique water-in-oilemulsion 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 disappears within seconds, leaving skin smooth and protected. Reapply as needed based on individual sun sensitivity.

US Distribution: Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www. annalotanusa.com

PRODUCT OF ISRAEL

Section 50565-1

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

Warnings

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

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

Stop use and ask a doctor • if rash occurs.

Packaging

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.

Drug Facts

Active Ingredients

Zinc Oxide 25%

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.

Questions Or Comments?

[email protected]

Tel.: (781) 281 0954


Structured Label Content

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.

Section 42229-5 (42229-5)

SUN Select

For all skin types

TENDER LOVING CARE

DERMATOLOGICALLY TESTED

FOR SENSITIVE SKIN

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 textureis 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 Bisabololand Allantoin, plus potent antioxidantssuch as Vitamin E (Tocopherol)and Hydroxyacetophenone, this formula helps prevent free radical damage essential during sun exposure.

Replenishing seed oilsand phytosterolsreinforce the skin's natural barrier, while Dead Seaminerals enhance long-lasting moisture retention. The unique water-in-oilemulsion 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 disappears within seconds, leaving skin smooth and protected. Reapply as needed based on individual sun sensitivity.

US Distribution: Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www. annalotanusa.com

PRODUCT OF ISRAEL

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.

Purpose

Sunscreen

Warnings

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

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

Stop use and ask a doctor • if rash occurs.

Packaging

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.

Drug Facts

Active Ingredients

Zinc Oxide 25%

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.

Questions Or Comments? (Questions or Comments?)

[email protected]

Tel.: (781) 281 0954


Advanced Ingredient Data


Raw Label Data

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