DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (2.3 g) Zinc Oxide (22 g)

Inactive Ingredients

Aluminum Oxide Aloe Vera Leaf Medium-chain Triglycerides Hydrogenated Jojoba Oil Calendula Officinalis Flower Green Tea Leaf Tocopherol Myristyl Glucoside Salicylic Acid Propanediol Stearyl Alcohol Undecane Xanthan Gum Benzyl Alcohol Sorbic Acid Arachidyl Glucoside Glycerin Myristyl Alcohol Arachidyl Alcohol Glyceryl Stearate Se Tridecane Sunflower Oil Chromic Oxide Brassica Rapa Subsp. Oleifera Whole

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2024-06-17 Until 2026-06-30

Medication Information

Indications and Usage

See "Uses" and "Warnings"

Dosage and Administration

Dosage: Cream

Route of adminstration: Topical

Description

Aloe Barbadensis Leaf Extract Aloe Barbadensis Leaf Juice Alumina Arachidyl Alcohol Arachidyl Glucoside Behenyl Alcohol Benzyl Alcohol Brassica Campestris/Aleurites Fordi Oil Copolymer Calendula Officinalis Flower Extract Camellia Sinensis Leaf Extract Caprylic/Capric Triglyceride Chromium Oxide Greens Glycerin Glyceryl Stearate SE Helianthus Annuus (Sunflower) Seed Oil Jojoba Esters Myristyl Alcohol Myristyl Glucoside Propanediol Salicylic Acid Sea Silt Sea Silt Extract Sorbic Acid Stearyl Alcohol, Tocopherols Tridecane Undecane Xanthan Gum

Uses

Helps prevent sunburn.

Helps protect from sunburn.

If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun.

Sun Protection Factor 30 / SPF 30.

Section 50565-1

Refer to "Keep out of reach of children" in "Warnings" section

Section 51945-4

Warnings

· For external use only

· Do not use • on damaged or broken skin.

· When using this product • keep out of eyes. Rinse with water to remove.

· Stop use and ask a doctor if • rash occurs.

· Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Children under 6 months of age: 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 the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating.

Drug Facts

Active ingredients (in each dosage unit) Purpose

Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen

Zinc oxide 22% .…………………….………………………………………………………. Sunscreen

Questions?

Email [email protected]

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract

Aloe Barbadensis Leaf Juice

Alumina

Arachidyl Alcohol

Arachidyl Glucoside

Behenyl Alcohol

Benzyl Alcohol

Brassica Campestris/Aleurites Fordi Oil Copolymer

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Caprylic/Capric Triglyceride

Chromium Oxide Greens

Glycerin

Glyceryl Stearate SE

Helianthus Annuus (Sunflower) Seed Oil

Jojoba Esters

Myristyl Alcohol

Myristyl Glucoside

Propanediol

Salicylic Acid

Sea Silt

Sea Silt Extract

Sorbic Acid

Stearyl Alcohol,

Tocopherols

Tridecane

Undecane

Xanthan Gum

Structured Label Content

Uses

Helps prevent sunburn.

Helps protect from sunburn.

If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun.

Sun Protection Factor 30 / SPF 30.

Indications and Usage (34067-9)

See "Uses" and "Warnings"

Dosage and Administration (34068-7)

Dosage: Cream

Route of adminstration: Topical

Section 50565-1 (50565-1)

Refer to "Keep out of reach of children" in "Warnings" section

Section 51945-4 (51945-4)

Warnings

· For external use only

· Do not use • on damaged or broken skin.

· When using this product • keep out of eyes. Rinse with water to remove.

· Stop use and ask a doctor if • rash occurs.

· Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Children under 6 months of age: 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 the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating.

Drug Facts

Active ingredients (in each dosage unit) Purpose

Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen

Zinc oxide 22% .…………………….………………………………………………………. Sunscreen

Questions?

Email [email protected]

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis Leaf Extract

Aloe Barbadensis Leaf Juice

Alumina

Arachidyl Alcohol

Arachidyl Glucoside

Behenyl Alcohol

Benzyl Alcohol

Brassica Campestris/Aleurites Fordi Oil Copolymer

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Caprylic/Capric Triglyceride

Chromium Oxide Greens

Glycerin

Glyceryl Stearate SE

Helianthus Annuus (Sunflower) Seed Oil

Jojoba Esters

Myristyl Alcohol

Myristyl Glucoside

Propanediol

Salicylic Acid

Sea Silt

Sea Silt Extract

Sorbic Acid

Stearyl Alcohol,

Tocopherols

Tridecane

Undecane

Xanthan Gum

Advanced Ingredient Data

[{"name": "ALUMINUM OXIDE", "unii": "LMI26O6933", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED JOJOBA OIL", "unii": "7F674YQ5SO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MYRISTYL GLUCOSIDE", "unii": "6AK28695LF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDECANE", "unii": "JV0QT00NUE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBIC ACID", "unii": "X045WJ989B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARACHIDYL GLUCOSIDE", "unii": "6JVW35JOOJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MYRISTYL ALCOHOL", "unii": "V42034O9PU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARACHIDYL ALCOHOL", "unii": "1QR1QRA9BU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIDECANE", "unii": "A3LZF0L939", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "22", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHROMIC OXIDE", "unii": "X5Z09SU859", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BRASSICA RAPA SUBSP. OLEIFERA WHOLE", "unii": "B0MET6L3EC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. Helps protect from sunburn. If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun. Sun Protection Factor 30 / SPF 30.", "34067-9": "See "Uses" and "Warnings"", "34068-7": "Dosage: Cream Route of adminstration: Topical", "50565-1": "Refer to "Keep out of reach of children" in "Warnings" section", "Warnings": "· For external use only · Do not use • on damaged or broken skin. · When using this product • keep out of eyes. Rinse with water to remove. · Stop use and ask a doctor if • rash occurs. · Keep out of reach of children . If swallowed, call a poison control centre or get medical help right away", "Directions": "Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months of age: 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 the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses. Use a water resistant sunscreen if swimming or sweating.", "Drug Facts": "Active ingredients (in each dosage unit) Purpose Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen Zinc oxide 22% .…………………….………………………………………………………. Sunscreen", "Questions?": "Email contact@nenaskincare.com", "Other information": "Protect the product in this container from excessive heat and direct sun.", "Inactive ingredients:": "Aloe Barbadensis Leaf Extract Aloe Barbadensis Leaf Juice Alumina Arachidyl Alcohol Arachidyl Glucoside Behenyl Alcohol Benzyl Alcohol Brassica Campestris/Aleurites Fordi Oil Copolymer Calendula Officinalis Flower Extract Camellia Sinensis Leaf Extract Caprylic/Capric Triglyceride Chromium Oxide Greens Glycerin Glyceryl Stearate SE Helianthus Annuus (Sunflower) Seed Oil Jojoba Esters Myristyl Alcohol Myristyl Glucoside Propanediol Salicylic Acid Sea Silt Sea Silt Extract Sorbic Acid Stearyl Alcohol, Tocopherols Tridecane Undecane Xanthan Gum"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information