8578 Spf 50 Baby Skin Mineral Sunscreen Lotion

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.0001 mL)

Inactive Ingredients

Calendula Officinalis Flower Pueraria Montana Var. Lobata Root Cetostearyl Alcohol Hyaluronate Sodium Sodium Stearoyl Glutamate Tocopherol Levomenol Glycerin Water Nasturtium Officinale Flowering Top Polyhydroxystearic Acid (2300 Mw) Sodium Gluconate Cetyl Alcohol Citric Acid Monohydrate Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Chamomile Butyloctyl Salicylate Arachidyl Alcohol Arachidyl Glucoside Docosanol Shea Butter Caprylhydroxamic Acid Methyl Dihydroabietate Coco Glucoside Coconut Oil Sunflower Oil Microcrystalline Cellulose Filipendula Ulmaria Flower Cocoa Butter Safflower Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-08-26 Until 2026-02-28

Medication Information

Purpose

Sunscree

Description

This is a sunscreen with the approved active ingredient of Zinc Oxide at 20%.

Use

Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 42229-5

This is a sunscreen with the approved active ingredient of Zinc Oxide at 20%.

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 doctor if rash occurs. • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Directions

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredient(s)

Zinc Oxide 20%. Purpose: Sunscreen

Inactive Ingredients

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA).*Certified Organic Ingredients

Package Label Principal Display Panel

3 fl oz / 89 mL ml NDC: 79265-8578-3

Structured Label Content

Use

Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 42229-5 (42229-5)

This is a sunscreen with the approved active ingredient of Zinc Oxide at 20%.

Purpose

Sunscree

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 doctor if rash occurs. • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.

Directions

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredient(s)

Zinc Oxide 20%. Purpose: Sunscreen

Inactive Ingredients (Inactive ingredients)

ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA).*Certified Organic Ingredients

Package Label Principal Display Panel (Package Label - Principal Display Panel)

3 fl oz / 89 mL ml NDC: 79265-8578-3

Advanced Ingredient Data

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LOBATA ROOT", "unii": "PET93F4I3C", "classCode": "IACT", "strengthNumerator": "0.0001", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "1.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM STEAROYL GLUTAMATE", "unii": "65A9F4P024", "classCode": "IACT", "strengthNumerator": "1.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "0.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "46.0495", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "NASTURTIUM OFFICINALE FLOWERING TOP", "unii": "W1N2U8I64G", "classCode": "IACT", "strengthNumerator": "0.0001", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYHYDROXYSTEARIC ACID (2300 MW)", "unii": "YXH47AOU0F", "classCode": "IACT", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "0.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "0.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "0.144", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "0.0001", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ARACHIDYL ALCOHOL", "unii": "1QR1QRA9BU", "classCode": "IACT", "strengthNumerator": "0.972", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ARACHIDYL GLUCOSIDE", "unii": "6JVW35JOOJ", "classCode": "IACT", "strengthNumerator": "0.324", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "IACT", "strengthNumerator": "0.504", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "2.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "classCode": "IACT", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "METHYL DIHYDROABIETATE", "unii": "7666FJ0J9F", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "COCO GLUCOSIDE", "unii": "ICS790225B", "classCode": "IACT", "strengthNumerator": "0.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "5.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "1.056", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "FILIPENDULA ULMARIA FLOWER", "unii": "06L18L32G6", "classCode": "IACT", "strengthNumerator": "0.0001", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "0.8", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SAFFLOWER OIL", "unii": "65UEH262IS", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.", "42229-5": "This is a sunscreen with the approved active ingredient of Zinc Oxide at 20%.", "Purpose": "Sunscree", "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 doctor if rash occurs. • Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.", "Directions": "Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.", "Other information": "Protect this product from excessive heat and direct sun", "Active Ingredient(s)": "Zinc Oxide 20%. Purpose: Sunscreen", "Inactive ingredients": "ARACHIDYL ALCOHOL, ARACHIDYL GLUCOSIDE, BEHENYL ALCOHOL, BISABOLOL*, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CALENDULA OFFICINALIS FLOWER EXTRACT*, CAPRYLHYDROXAMIC ACID, CAPRYLYL GLYCOL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CELLULOSE GUM, CETEARYL ALCOHOL, CETYL ALCOHOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, CITRIC ACID, COCO-GLUCOSIDE, COCOS NUCIFERA (COCONUT) OIL, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, METHYL DIHYDROABIETATE, MICROCRYSTAL-LINE CELLULOSE, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, POLYHYDROXYSTEARIC ACID, PUERARIA LOBATA ROOT EXTRACT*, SODIUM GLUCONATE, SODIUM HYALURONATE, SODIUM STEAROYL GLUTAMATE, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, WATER (AQUA).*Certified Organic Ingredients", "Package Label - Principal Display Panel": "3 fl oz / 89 mL ml NDC: 79265-8578-3"}

8578 Spf 50 Baby Skin Mineral Sunscreen Lotion

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information