DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.21 g) Octinoxate (0.07 g)

Inactive Ingredients

Carbomer Ceramide 9 Butyrospermum Parkii (shea) Butter Helianthus Annuus (sunflower) Seed Oil Ceramide Np Water Simmondsia Chinensis (jojoba) Seed Oil Niacinamide Phytosphingosine Ethylhexyl Palmitate Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate Disteardimonium Hectorite Ethylhexylglycerin Cocos Nucifera (coconut) Oil Ceramide Ap Polyglyceryl-3 Oleate Vitis Vinifera (grape) Seed Oil Xanthan Gum Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Polymethylsilsesquioxane (11 Microns) Ceramide Eos Butyloctyl Salicylate Bht Cholesterol C12-15 Alkyl Benzoate Caprylic/capric Triglyceride Alcohol Fragrance 13576 Citrus Aurantium Bergamia (bergamot) Fruit Oil Tocopherol Isododecane Glycerin Phenoxyethanol Sodium Lauroyl Lactylate

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2026-01-15

Medication Information

Warnings and Precautions

Warnings

For external use only.

Skin cancer/skin aging alert .

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use m on damaged or broken skin.

When using this product keep out of eyes. rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children.If product is swallowed get medical help or contact a poison center center night away,

Indications and Usage

Helps prevent sunburn.

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Shake it up and down 3-5 seconds before use.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Description

Zinc Oxide 21%, Octinoxate 7%

Section 50565-1

If product is swallowed get medical help or contact a poison control center night away.

Section 51727-6

C12-15 ALKYL BENZOATE, WATER, ETHYLHEXYL PALMITATE, ISODODECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., COCOS NUCIFERA (COCONUT) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PHENOXYETHANOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, POLYGLYCERYL-3 OLEATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE, DISTEARDIMONIUM HECTORITE, TOCOPHEROL, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, VITIS VINIFERA (GRAPE) SEED OIL, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, BHT, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, CHOLESTEROL, CERAMIDE AP, PHYTOSPHINGOSINE, XANTHAN GUM, CARBOMER, CERAMIDE EOP

Section 51945-4

Section 53413-1

1-212-244-5170

[email protected]

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 21%, Octinoxate 7%

Section 60561-8

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

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn.

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Shake it up and down 3-5 seconds before use.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Skin cancer/skin aging alert .

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use m on damaged or broken skin.

When using this product keep out of eyes. rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children.If product is swallowed get medical help or contact a poison center center night away,

Section 50565-1 (50565-1)

If product is swallowed get medical help or contact a poison control center night away.

Section 51727-6 (51727-6)

C12-15 ALKYL BENZOATE, WATER, ETHYLHEXYL PALMITATE, ISODODECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., COCOS NUCIFERA (COCONUT) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PHENOXYETHANOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, POLYGLYCERYL-3 OLEATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE, DISTEARDIMONIUM HECTORITE, TOCOPHEROL, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, VITIS VINIFERA (GRAPE) SEED OIL, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, BHT, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, CHOLESTEROL, CERAMIDE AP, PHYTOSPHINGOSINE, XANTHAN GUM, CARBOMER, CERAMIDE EOP

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212-244-5170

[email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 21%, Octinoxate 7%

Section 60561-8 (60561-8)

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

Advanced Ingredient Data

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"IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISODODECANE", "unii": "A8289P68Y2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROYL LACTYLATE", "unii": "7243K85WFO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn.", "34068-7": "Directions Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Shake it up and down 3-5 seconds before use. Use a water resistant sunscreen if swimming or sweating. Children under 6 month: ask a doctor.", "34071-1": "Warnings For external use only. Skin cancer/skin aging alert . Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Do not use m on damaged or broken skin. When using this product keep out of eyes. rinse with water to remove. Stop use and ask doctor if rash occurs. Keep out of reach of children. If product is swallowed get medical help or contact a poison center center night away,", "50565-1": "If product is swallowed get medical help or contact a poison control center night away.", "51727-6": "C12-15 ALKYL BENZOATE, WATER, ETHYLHEXYL PALMITATE, ISODODECANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, BUTYLOCTYL SALICYLATE, ALCOHOL DENAT., COCOS NUCIFERA (COCONUT) OIL, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PHENOXYETHANOL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, POLYGLYCERYL-3 OLEATE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE, DISTEARDIMONIUM HECTORITE, TOCOPHEROL, FRAGRANCE, BUTYROSPERMUM PARKII (SHEA) BUTTER, VITIS VINIFERA (GRAPE) SEED OIL, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, BHT, SODIUM LAUROYL LACTYLATE, CERAMIDE NP, CHOLESTEROL, CERAMIDE AP, PHYTOSPHINGOSINE, XANTHAN GUM, CARBOMER, CERAMIDE EOP", "53413-1": "1-212-244-5170 INFO@AMORA.BEAUTY", "55105-1": "Sunscreen", "55106-9": "Zinc Oxide 21%, Octinoxate 7%", "60561-8": "Protect the product in this container from excessive heat and direct sun."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information