Anna Lotan

Anna Lotan
SPL v3
SPL
SPL Set ID f74f6d59-fc49-49e1-9763-daab29c47cb4
Route
TOPICAL
Published
Effective Date 2022-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (7.75 g) Zinc Oxide (10 g)
Inactive Ingredients
Butyloctyl Salicylate Glycerin Dimethicone Styrene/acrylamide Copolymer (500000 Mw) Cocoyl Caprylocaprate Aluminum Stearate Carthamus Tinctorius Seed Oleosomes Polyhydroxystearic Acid (2300 Mw) Aloe Vera Leaf Polygonum Aviculare Top .alpha.-tocopherol Acetate Perilla Frutescens Leaf Vitis Vinifera High Tannin Cultivar Fruit Cell Lysate Garden Cress Sprout Squalane Cetostearyl Alcohol Isononyl Isononanoate Coco Glucoside Pentylene Glycol Docosanol Xanthan Gum Triethoxycaprylylsilane Arachidyl Glucoside Jojoba Oil Stearic Acid Sucrose Stearate Phenylethyl Alcohol Tetrahexyldecyl Ascorbate Glyceryl Monocaprylate Sorbitan Monooleate Polyglyceryl-2 Caprate Propanediol Aluminum Oxide Arachidyl Alcohol Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide Water Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-25

Description

Titanium Dioxide 7.75% Zinc Oxide 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7.75% Zinc Oxide 10.0%

Uses

helps 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

For all skin types

This lightly tinted daytime moisturizer provides broad spectrum protection based on minerals aloneexcluding chemical absorbers.

The formula is enriched with skin friendly, sustainable emollients which are easily absorbed by the skin while minimizing the white appearance common to mineral based sunscreens.

A wide range of free radical scavengers provides the antioxidant protectionwhich is vital during exposure to UV light.

Vitamin Esupported by a stable ester form of Vitamin Cprotects the skin’s own lipids as well as the seed oils in the formula.

Extracts of Garden Cresssprouts and Grapescontribute their antioxidants to the water based part of the composition.

Distributed by: Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www.annalotanusa.com

[email protected]

Section 50565-1

Keep out of reach of children.

Purpose:

Sunscreen

Warnings

For external use only.

Do not use ondamaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Packaging

Directions

• apply to all skin exposed to the sun

• apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use water resistant sunscreen if swimming or sweating 

• for children under 6 months: Ask a doctor

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 sun from 10 a.m.- 2 p.m.    

   • wear long-sleeved shirts, pants, hats and sunglasses

Drug Facts

Other Information

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

Active Ingredients

Titanium Dioxide 7.75%

Zinc Oxide 10.0%

Inactive Ingredients

water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (CI 77492, CI 77491, CI 77499).

Questions Or Comments?

(781) 281-0954


Structured Label Content

Uses

helps 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)

For all skin types

This lightly tinted daytime moisturizer provides broad spectrum protection based on minerals aloneexcluding chemical absorbers.

The formula is enriched with skin friendly, sustainable emollients which are easily absorbed by the skin while minimizing the white appearance common to mineral based sunscreens.

A wide range of free radical scavengers provides the antioxidant protectionwhich is vital during exposure to UV light.

Vitamin Esupported by a stable ester form of Vitamin Cprotects the skin’s own lipids as well as the seed oils in the formula.

Extracts of Garden Cresssprouts and Grapescontribute their antioxidants to the water based part of the composition.

Distributed by: Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www.annalotanusa.com

[email protected]

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose:

Sunscreen

Warnings

For external use only.

Do not use ondamaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Packaging

Directions

• apply to all skin exposed to the sun

• apply liberally 15 minutes before sun exposure

• reapply at least every 2 hours

• use water resistant sunscreen if swimming or sweating 

• for children under 6 months: Ask a doctor

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 sun from 10 a.m.- 2 p.m.    

   • wear long-sleeved shirts, pants, hats and sunglasses

Drug Facts

Other Information (Other information)

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

Active Ingredients

Titanium Dioxide 7.75%

Zinc Oxide 10.0%

Inactive Ingredients (Inactive ingredients)

water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (CI 77492, CI 77491, CI 77499).

Questions Or Comments? (Questions or Comments?)

(781) 281-0954


Advanced Ingredient Data


Raw Label Data

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