8579 Babo Spf 30 Baby Skin Mineral Non-aerosol Sunscreen Pump Spray, Ff

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.00015 mL)

Inactive Ingredients

Pueraria Montana Var. Lobata Root Tetradecane Water Bentonite Caprylyl Glycol Levomenol Cetostearyl Alcohol Chamomile Glycerin Sunflower Oil Hydrogenated Jojoba Oil, Randomized Methyl Dihydroabietate Propanediol Carboxymethylcellulose Sodium, Unspecified Form Butyloctyl Salicylate Calendula Officinalis Flower Caprylhydroxamic Acid Medium-chain Triglycerides Safflower Oil Coco Glucoside Microcrystalline Cellulose Nasturtium Officinale Flowering Top Polyhydroxystearic Acid (2300 Mw) Filipendula Ulmaria Flower Tocopherol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-11-01 Until 2024-12-31

Medication Information

Purpose

Sunscreen

Description

This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

Uses

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 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Section 51945-4

79265-8579-6 6 fl. oz. / 177 mL

Warnings

For external use only.

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.

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 the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months; ask a doctor.

Do Not Use

on damaged or broken skin.

Active Ingredient

Zinc Oxide 14.5%; Purpose: Sunscreen

Other Information

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Inactive Ingredients

BENTONITE

BISABOLOL*

BUTYLOCTYL SALICYLATE

CALENDULA OFFICINALIS FLOWER EXTRACT*

CAPRYLHYDROXAMIC ACID

CAPRYLIC/CAPRIC TRIGLYCERIDE

CAPRYLYL GLYCOL

CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL

CELLULOSE GUM

CETEARYL ALCOHOL

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*

COCO GLUCOSIDE

GLYCERIN*

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*

JOJOBA ESTERS

METHYL DIHYDROABIETATE

MICROCRYSTALLINE CELLULOSE

NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*

POLYHYDROXYSTEARIC ACID

PROPANEDIOL

PUERARIA LOBATA (KUDZU) ROOT EXTRACT*

SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*

TETRADECANE

TOCOPHEROL

WATER (AQUA)

Questions and Comments

Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST

Stop Use and Ask Doctor

if rash occurs

When Using This Product

Keep out of eye. Rinse with water to remove.

Spf 30 Baby Skin Mineral Non Aerosol Sunscreen Pump Spray, Ff

This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

Structured Label Content

Uses

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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Section 51945-4 (51945-4)

79265-8579-6 6 fl. oz. / 177 mL

Purpose

Sunscreen

Warnings

For external use only.

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.

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 the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months; ask a doctor.

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredient

Zinc Oxide 14.5%; Purpose: Sunscreen

Other Information (Other information)

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

Inactive Ingredients

BENTONITE

BISABOLOL*

BUTYLOCTYL SALICYLATE

CALENDULA OFFICINALIS FLOWER EXTRACT*

CAPRYLHYDROXAMIC ACID

CAPRYLIC/CAPRIC TRIGLYCERIDE

CAPRYLYL GLYCOL

CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL

CELLULOSE GUM

CETEARYL ALCOHOL

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*

COCO GLUCOSIDE

GLYCERIN*

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*

JOJOBA ESTERS

METHYL DIHYDROABIETATE

MICROCRYSTALLINE CELLULOSE

NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT*

POLYHYDROXYSTEARIC ACID

PROPANEDIOL

PUERARIA LOBATA (KUDZU) ROOT EXTRACT*

SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT*

TETRADECANE

TOCOPHEROL

WATER (AQUA)

Questions and Comments (Questions and comments)

Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST

Stop Use and Ask Doctor (Stop use and ask doctor)

if rash occurs

When Using This Product (When using this product)

Keep out of eye. Rinse with water to remove.

Spf 30 Baby Skin Mineral Non Aerosol Sunscreen Pump Spray, Ff (SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF)

This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide

Advanced Ingredient Data

[{"name": "PUERARIA MONTANA VAR. LOBATA ROOT", "unii": "PET93F4I3C", "classCode": "IACT", "strengthNumerator": "0.00015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TETRADECANE", "unii": "03LY784Y58", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "53.8608", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BENTONITE", "unii": "A3N5ZCN45C", "classCode": "IACT", "strengthNumerator": "1.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "0.7", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CETOSTEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "1.105", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "0.00015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.15845", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "HYDROGENATED JOJOBA OIL, RANDOMIZED", "unii": "Q47ST02F58", "classCode": "IACT", "strengthNumerator": "0.38", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "METHYL DIHYDROABIETATE", "unii": "7666FJ0J9F", "classCode": "IACT", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PROPANEDIOL", "unii": "5965N8W85T", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "0.09", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "0.00015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLHYDROXAMIC ACID", "unii": "UPY805K99W", "classCode": "IACT", "strengthNumerator": "0.15", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "SAFFLOWER OIL", "unii": "65UEH262IS", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "COCO GLUCOSIDE", "unii": "ICS790225B", "classCode": "IACT", "strengthNumerator": "0.595", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "0.66", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "NASTURTIUM OFFICINALE FLOWERING TOP", "unii": "W1N2U8I64G", "classCode": "IACT", "strengthNumerator": "0.00015", "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": "FILIPENDULA ULMARIA FLOWER", "unii": "06L18L32G6", "classCode": "IACT", "strengthNumerator": "0.00015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "0.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "14.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.", "51945-4": "79265-8579-6 6 fl. oz. / 177 mL", "Purpose": "Sunscreen", "Warnings": "For external use only.", "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. 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 the sun, especially from 10 a.m. – 2 p.m. and wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months; ask a doctor.", "Do not use": "on damaged or broken skin.", "Active Ingredient": "Zinc Oxide 14.5%; Purpose: Sunscreen", "Other information": "Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.", "Inactive Ingredients": "BENTONITE BISABOLOL* BUTYLOCTYL SALICYLATE CALENDULA OFFICINALIS FLOWER EXTRACT* CAPRYLHYDROXAMIC ACID CAPRYLIC/CAPRIC TRIGLYCERIDE CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL CELLULOSE GUM CETEARYL ALCOHOL CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT* COCO GLUCOSIDE GLYCERIN* HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL* JOJOBA ESTERS METHYL DIHYDROABIETATE MICROCRYSTALLINE CELLULOSE NASTURTIUM OFFICINALE (WATERCRESS) FLOWER/LEAF EXTRACT* POLYHYDROXYSTEARIC ACID PROPANEDIOL PUERARIA LOBATA (KUDZU) ROOT EXTRACT* SPIRAEA ULMARIA (MEADOWSWEET) FLOWER EXTRACT* TETRADECANE TOCOPHEROL WATER (AQUA)", "Questions and comments": "Call toll free 1-877-537-BABO Monday-Friday 9:00 am - 5:00 EST", "Stop use and ask doctor": "if rash occurs", "When using this product": "Keep out of eye. Rinse with water to remove.", "SPF 30 Baby Skin Mineral Non-Aerosol Sunscreen Pump Spray, FF": "This product is an OTC sunscreen manufactured according to the Sunscreen Final Rule. Active ingredient: Zinc Oxide"}

8579 Babo Spf 30 Baby Skin Mineral Non-aerosol Sunscreen Pump Spray, Ff

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information