8068 Babo Botanicals Spf 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

SPL v3

SPL

SPL Set ID b20d4019-643b-60fe-e053-2a95a90a8729

Route

TOPICAL

Published

Effective Date 2020-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (0.5362 mL)

Inactive Ingredients

Ferric Oxide Red Pueraria Montana Var. Lobata Root Filipendula Ulmaria Flower Hippophae Rhamnoides Fruit Sunflower Oil Trihydroxystearin Hydrogenated Jojoba Oil, Randomized Nasturtium Officinale Flowering Top Rosa Canina Fruit Jojoba Oil Cocoa Butter Argania Spinosa Seed Tocopherol Avocado Oil Rice Bran Oil Candelilla Wax Arabica Coffee Bean Octyldodecyl Oleate Calendula Officinalis Flower Shea Butter Calophyllum Tacamahaca Seed Oil Chamomile White Wax Levomenol Octyldodecanol Oryzanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-11-01 Until 2026-02-28

Description

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Uses

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.

Warnings

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

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

Do Not Use

Do not use on damaged or broken skin

Drug Facts Panel

79265-8068-0

Information Panel

79265-8068-0 INFORMATION PANEL

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 20.2115%

Inactive Ingredients

ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN.

*CERTIFIED ORGANIC INGREDIENT

Questions / Comments?

Questions and comments: Call 1-877-537-BABO

Primary Container Label

79265-8068-1

Principal Display Panel

0.6 oz. 17 g 79265-8068-0

When Using This Product

When using this product Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor

Stop use and ask doctor if rash occurs

Keep Out of Reach of Children

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

79265 8068 0 Spf 50 Tinted Face Mineral Fragrance Free Sunscreen Stick

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Structured Label Content

Uses (USES)

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.

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

Directions (DIRECTIONS)

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

Do Not Use (DO NOT USE)

Do not use on damaged or broken skin

Drug Facts Panel (DRUG FACTS PANEL)

79265-8068-0

Information Panel (INFORMATION PANEL)

79265-8068-0 INFORMATION PANEL

Other Information (OTHER INFORMATION)

Protect this product from excessive heat and direct sun.

Active Ingredients (ACTIVE INGREDIENTS)

Zinc Oxide 20.2115%

Inactive Ingredients (INACTIVE INGREDIENTS)

*CERTIFIED ORGANIC INGREDIENT

Questions / Comments? (QUESTIONS / COMMENTS?)

Questions and comments: Call 1-877-537-BABO

Primary Container Label

79265-8068-1

Principal Display Panel

0.6 oz. 17 g 79265-8068-0

When Using This Product (WHEN USING THIS PRODUCT)

When using this product Keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (STOP USE AND ASK A DOCTOR)

Stop use and ask doctor if rash occurs

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

79265 8068 0 Spf 50 Tinted Face Mineral Fragrance Free Sunscreen Stick (79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick)

This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph.

Advanced Ingredient Data

[{"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "0.5362", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "PUERARIA MONTANA VAR. LOBATA ROOT", "unii": "PET93F4I3C", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "FILIPENDULA ULMARIA FLOWER", "unii": "06L18L32G6", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "HIPPOPHAE RHAMNOIDES FRUIT", "unii": "AVL0R9111T", "classCode": "IACT", "strengthNumerator": "0.00125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "0.1875", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "TRIHYDROXYSTEARIN", "unii": "06YD7896S3", "classCode": "IACT", "strengthNumerator": "0.0092", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "HYDROGENATED JOJOBA OIL, RANDOMIZED", "unii": "Q47ST02F58", "classCode": "IACT", "strengthNumerator": "0.9023", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "NASTURTIUM OFFICINALE FLOWERING TOP", "unii": "W1N2U8I64G", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "ROSA CANINA FRUIT", "unii": "3TNW8D08V3", "classCode": "IACT", "strengthNumerator": "0.00125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "ARGANIA SPINOSA SEED", "unii": "8H7X7XB54H", "classCode": "IACT", "strengthNumerator": "0.00125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "0.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "AVOCADO OIL", "unii": "6VNO72PFC1", "classCode": "IACT", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "RICE BRAN OIL", "unii": "LZO6K1506A", "classCode": "IACT", "strengthNumerator": "23.07", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "CANDELILLA WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "9.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "IACT", "strengthNumerator": "0.00125", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "OCTYLDODECYL OLEATE", "unii": "MCA43PK7MH", "classCode": "IACT", "strengthNumerator": "8.75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "CALENDULA OFFICINALIS FLOWER", "unii": "P0M7O4Y7YD", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "CALOPHYLLUM TACAMAHACA SEED OIL", "unii": "05G85L61OE", "classCode": "IACT", "strengthNumerator": "0.01", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "0.0015", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "LEVOMENOL", "unii": "24WE03BX2T", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "0.3608", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "ORYZANOL", "unii": "SST9XCL51M", "classCode": "IACT", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "20.2115", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USES": "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.", "PURPOSE": "SUNSCREEN", "WARNINGS": "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": "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", "DO NOT USE": "Do not use on damaged or broken skin", "DRUG FACTS PANEL": "79265-8068-0", "INFORMATION PANEL": "79265-8068-0 INFORMATION PANEL", "OTHER INFORMATION": "Protect this product from excessive heat and direct sun.", "ACTIVE INGREDIENTS": "Zinc Oxide 20.2115%", "INACTIVE INGREDIENTS": "ARGANIA SPINOSA KERNEL EXTRACT, BEESWAX*, BISABOLOL*, BUTYROSPERMUM PARKII (SHEA) BUTTER*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, COFFEA ARABICA (COFFEE) SEED EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, IRON OXIDES, JOJOBA ESTERS, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, OCTYLDODECANOL, OCTYLDODECYL OLEATE, ORYZANOL, ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, PUERARIA LOBATA ROOT EXTRACT*, ROSA CANINA FRUIT EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, SPIRAEA ULMARIA FLOWER EXTRACT*, THEOBROMA CACAO (COCOA) SEED BUTTER*, TOCOPHEROL, TRIHYDROXYSTEARIN. *CERTIFIED ORGANIC INGREDIENT", "QUESTIONS / COMMENTS?": "Questions and comments: Call 1-877-537-BABO", "Primary Container Label": "79265-8068-1", "Principal Display Panel": "0.6 oz. 17 g 79265-8068-0", "WHEN USING THIS PRODUCT": "When using this product Keep out of eyes. Rinse with water to remove", "STOP USE AND ASK A DOCTOR": "Stop use and ask doctor if rash occurs", "KEEP OUT OF REACH OF CHILDREN": "Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.", "79265-8068-0 SPF 50 Tinted Face Mineral Fragrance Free Sunscreen Stick": "This product is a mineral sunscreen semi solid stick manufactured pursuant to the sunscreen final monograph."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.724465 · Updated: 2026-03-14T23:05:50.099426