broad spectrum spf 30 natural mineral formula

Drug Facts

Composition & Product

Active Ingredients

zinc cation (8.25 g)

Inactive Ingredients

sunflower oil yellow wax jojoba oil coconut oil tocopherol

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2019-08-16

Medication Information

Warnings and Precautions

Warnings

For External Use Only

Active Ingredient

Active Ingredients:

Zinc Oxide (18.75%) Non-nanoparticle

Uses

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration

Directions •Apply liberally 15 minutes before sun exposure

• Reapply after 80 minutes of swimming or sweating, •Reapply

• immediately after towel drying. •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 protection measures including:

• limit time in the sun, especially from 10a.m. - 2p.m.

• wear long sleeved shirts, pants, hat, and sunglasses.

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Section 50566-9

Stop use and as a doctor if • rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*,

Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*,

non-GMO Tocopherol (Vitamin E).

*Organic Ingredients

Section 60561-8

Other Information: Protect this product from excessive heart and direct sun.

Product Package Labeling

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

WATER RESISTANT

(80 MINUTES)

1.5 fl. oz. / 44 ml

L000000

Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

Made in the USA

1.5 fl. oz. / 44 ml

L000000

rege

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For External Use Only

Active Ingredient (55106-9)

Active Ingredients:

Zinc Oxide (18.75%) Non-nanoparticle

Uses

Helps prevent sunburn

Purpose

Sunscreen

Dosage and Administration (34068-7)

Directions •Apply liberally 15 minutes before sun exposure

• Reapply after 80 minutes of swimming or sweating, •Reapply

• immediately after towel drying. •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 protection measures including:

• limit time in the sun, especially from 10a.m. - 2p.m.

• wear long sleeved shirts, pants, hat, and sunglasses.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and as a doctor if • rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*,

Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*,

non-GMO Tocopherol (Vitamin E).

*Organic Ingredients

Section 60561-8 (60561-8)

Other Information: Protect this product from excessive heart and direct sun.

Product Package Labeling

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

WATER RESISTANT

(80 MINUTES)

1.5 fl. oz. / 44 ml

L000000

Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

Made in the USA

1.5 fl. oz. / 44 ml

L000000

rege

Advanced Ingredient Data

[{"name": "ZINC CATION", "unii": "13S1S8SF37", "classCode": "ACTIM", "strengthNumerator": "8.25", "strengthDenominator": "44", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "JOJOBA OIL", "unii": "724GKU717M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn", "34068-7": "Directions •Apply liberally 15 minutes before sun exposure • Reapply after 80 minutes of swimming or sweating, •Reapply • immediately after towel drying. •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 protection measures including: • limit time in the sun, especially from 10a.m. - 2p.m. • wear long sleeved shirts, pants, hat, and sunglasses.", "34071-1": "Warnings For External Use Only ", "42229-5": "DRUG FACTS", "50565-1": "Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.", "50566-9": "Stop use and as a doctor if • rash occurs", "50567-7": "When using this product • Keep out of eyes. Rinse well with water to remove.", "50570-1": "Do not use on damaged or broken skin", "51727-6": "Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*, Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*, non-GMO Tocopherol (Vitamin E). *Organic Ingredients", "55106-9": "Active Ingredients: Zinc Oxide (18.75%) Non-nanoparticle", "60561-8": "Other Information: Protect this product from excessive heart and direct sun.", "Purpose": "Sunscreen", "Product Package Labeling": "Dist. by : Raining Rose, Inc., Cedar Rapids, IA 52403 Broad Spectrum SPF 30 Sunscreen NATURAL MINERAL FORMULA WATER RESISTANT (80 MINUTES) 1.5 fl. oz. / 44 ml L000000 Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403 Broad Spectrum SPF 30 Sunscreen NATURAL MINERAL FORMULA Made in the USA 1.5 fl. oz. / 44 ml L000000 rege"}

broad spectrum spf 30 natural mineral formula

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information