Anna Lotan

Anna Lotan
SPL v4
SPL
SPL Set ID f54faf2d-e1a9-4efe-80d9-43fbdb00ceed
Route
TOPICAL
Published
Effective Date 2023-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (16 g) Octinoxate (6.99 g)
Inactive Ingredients
Water Medium-chain Triglycerides Dicaprylyl Ether Cyclomethicone 5 Talc Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Dimethicone, Unspecified Cyclomethicone 6 Cetearyl Ethylhexanoate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Dipalmitoyl Hydroxyproline Myristyl Myristate Phenoxyethanol Stearalkonium Hectorite Microcrystalline Wax Sodium Chloride Paraffin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Propylene Carbonate Ethylhexylglycerin Tocopherol Sunflower Oil Butylated Hydroxytoluene Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-15

Description

Titanium Dioxide 16% Octinoxate 6.99%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 16% Octinoxate 6.99%

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

PRO

SUN Select

Pale Beige 1

for normal/dry skin

A multi-functional formula that serves as an optimal day care for normal to dry skin types, giving long lasting coverage, moisturisation and a wrinkle-relaxing effect.

• A concentrated formula. A little will go a long way.

• Applied in the morning, still looks great at the end of a busy day.

• Formulated as a W/O emulsion that naturally repels water. However, care should be taken when regularly used on skin with enlarged pores!

• Excellent spreading and adherence on the skin, offering optimal coverage for discolorations, including under eye dark circles!

• A targeted combination of the amino acid proline and palm oil enhances skin penetration and provides a “plumping” anti-wrinkle effect, making it ideal for dry, mature skin.

• Enriched with emollient oils that smooth the skin and prevent the typical accentuation of fine lines common with many concealing makeup products.

• Vitamin E acts as antioxidant minimizing free radical damage.

• Premium BB Cream combines concealing opacity with a light translucent veil which becomes apparent once the cream is fully absorbed. This veil allows your natural skin tone to shine through.

Directions:Using sparingly, carefully spread the cream with fingertip massage to form an even layer on face, under eye area or wherever required until a smooth, even coverage is obtained.

US Distribution:Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www.annalotanusa.com

Section 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 useon damaged or broken skin.

When using this productkeep out of eyes. If contact occurs rinse thoroughly with water to remove.

Stop use and ask a doctorif 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

Titanium Dioxide 16%

Octinoxate 6.99%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Cyclopentasiloxane, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Cyclohexasiloxane, Cetearyl Ethylhexanoate, Methyl Methacrylate Crosspolymer, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Phenoxyethanol, Stearalkonium Hectorite, Microcrystalline Wax, Sodium Chloride, Paraffin, Polysilicone-11, Propylene Carbonate, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, BHT, Iron Oxides (CI 77491, CI 77492, CI 77499).

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)

PRO

SUN Select

Pale Beige 1

for normal/dry skin

A multi-functional formula that serves as an optimal day care for normal to dry skin types, giving long lasting coverage, moisturisation and a wrinkle-relaxing effect.

• A concentrated formula. A little will go a long way.

• Applied in the morning, still looks great at the end of a busy day.

• Formulated as a W/O emulsion that naturally repels water. However, care should be taken when regularly used on skin with enlarged pores!

• Excellent spreading and adherence on the skin, offering optimal coverage for discolorations, including under eye dark circles!

• A targeted combination of the amino acid proline and palm oil enhances skin penetration and provides a “plumping” anti-wrinkle effect, making it ideal for dry, mature skin.

• Enriched with emollient oils that smooth the skin and prevent the typical accentuation of fine lines common with many concealing makeup products.

• Vitamin E acts as antioxidant minimizing free radical damage.

• Premium BB Cream combines concealing opacity with a light translucent veil which becomes apparent once the cream is fully absorbed. This veil allows your natural skin tone to shine through.

Directions:Using sparingly, carefully spread the cream with fingertip massage to form an even layer on face, under eye area or wherever required until a smooth, even coverage is obtained.

US Distribution:Anna Lotan USA Inc.

16 Wheeling Ave, Woburn, MA 01801

www.annalotanusa.com

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 useon damaged or broken skin.

When using this productkeep out of eyes. If contact occurs rinse thoroughly with water to remove.

Stop use and ask a doctorif 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

Titanium Dioxide 16%

Octinoxate 6.99%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Dicaprylyl Ether, Cyclopentasiloxane, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Cyclohexasiloxane, Cetearyl Ethylhexanoate, Methyl Methacrylate Crosspolymer, Dipalmitoyl Hydroxyproline, Myristyl Myristate, Phenoxyethanol, Stearalkonium Hectorite, Microcrystalline Wax, Sodium Chloride, Paraffin, Polysilicone-11, Propylene Carbonate, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, BHT, Iron Oxides (CI 77491, CI 77492, CI 77499).

Questions Or Comments (Questions or comments)

[email protected]

Tel: (781) 281 0954


Advanced Ingredient Data


Raw Label Data

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