moisturizer sunscreen spf 50

moisturizer sunscreen spf 50
SPL v2
SPL
SPL Set ID 0402c4ba-ff2a-cf25-e063-6294a90a776c
Route
topical
Published
Effective Date 2023-08-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (4.93 mg) octinoxate (3.75 mg)
Inactive Ingredients
water heptyl undecylenate safflower oil glycerin coconut oil caprylic/capric/lauric triglyceride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-08-24

Purpose

Sunscreen

Description

Zinc Oxide 9.86% Octinoxate 7.5%


Medication Information

Warnings

Warnings When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Indications and Usage

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours.

Purpose

Sunscreen

Directions

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.

Children under six months of age: Consult a doctor.

Inactive Ingredients

Inactive Ingredients: Aqua, Glycerin, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Polyglyceryl-6 Distearate, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Carbomer, Disodium EDTA, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Phenoxyethanol, Ethylhexylglycerin.

*Certified Organic

Description

Zinc Oxide 9.86% Octinoxate 7.5%

Principal Display Panel

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Active Ingredients

Zinc Oxide 9.86%

Octinoxate 7.5%


Structured Label Content

Warnings

Warnings When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children
Indications and Usage (34067-9)

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours.

Purpose

Sunscreen

Directions

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.

Children under six months of age: Consult a doctor.

Inactive Ingredients

Inactive Ingredients: Aqua, Glycerin, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Polyglyceryl-6 Distearate, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Carbomer, Disodium EDTA, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Phenoxyethanol, Ethylhexylglycerin.

*Certified Organic

Principal Display Panel

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Active Ingredients

Zinc Oxide 9.86%

Octinoxate 7.5%


Advanced Ingredient Data


Raw Label Data

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