ANNA LOTAN ULTRA-GENTLE SHEER MINERAL PROTECTION UVA/UVB SPF50- zinc oxide lotion

anna lotan Ultra-gentle Sheer Mineral Protection UVA/UVB SPF50 by

Drug Labeling and Warnings

anna lotan Ultra-gentle Sheer Mineral Protection UVA/UVB SPF50 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 25%

Purpose

Sunscreen

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.

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.

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

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.

Questions or Comments?

info@annalotan.us

Tel.: (781) 281 0954

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

ANNA LOTAN ULTRA-GENTLE SHEER MINERAL PROTECTION UVA/UVB SPF50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-314
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C15-19 ALKANE (UNII: CI87N1IM01)
GLYCERIN (UNII: PDC6A3C0OX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SEA SALT (UNII: 87GE52P74G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
LEVOMENOL (UNII: 24WE03BX2T)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALLANTOIN (UNII: 344S277G0Z)
HYDROGENATED PALM OIL (UNII: 257THB963H)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
SOYBEAN OIL (UNII: 241ATL177A)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-314-50	1 in 1 BOX	10/31/2025
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/31/2025

Labeler - Anna Lotan Ltd (600458368)

Establishment
Name	Address	ID/FEI	Business Operations
Anna Lotan Ltd		600458368	manufacture(76446-314)