everyday sun defense

everyday sun defense
SPL v4
SPL
SPL Set ID 05aa1a1a-9e4f-2781-e063-6394a90aef6b
Route
topical
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (9.4 g)
Inactive Ingredients
argan oil ethyl ferulate phenoxyethanol ammonium acryloyldimethyltaurate/vp copolymer squalane cetostearyl alcohol caprylyl/capryl oligoglucoside triethoxycaprylylsilane water .alpha.-tocopherol acetate, d- sodium chloride alpha-tocopherol acetate glycerin propylene glycol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) dimethicone alkyl (c12-15) benzoate coco glucoside c14-22 alcohols c12-20 alkyl glucoside ethylhexylglycerin omega-3 fatty acids gluconolactone benzyl alcohol sorbic acid sodium benzoate shea butter urea chlorphenesin polyester-5 (tg-38) levomenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-01

Purpose

Sunscreen

Description

Zinc Oxide 9.4%


Medication Information

Warnings and Precautions

- 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 a doctor if rash occurs

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

Purpose

Sunscreen

Dosage and Administration

- Apply generously 15 minutes before sun exposure

- Reapply every 2 hours

- Use a water-resistant sunscreen if swimming or sweating

Description

Zinc Oxide 9.4%

Section 51945-4

Otc Purpose

Sunscreen

Otc Stop Use

Stop use if rash occurs

Otc Questions

+1) 866-322-3010

Otc Ask Doctor



Ask a doctor if rash occurs

Otc Do Not Use

Do not use on damaged or broken skin

Otc When Using

When using this product keep out of eyes

Rinse with water to remove

Active Ingredient

Zinc Oxide 9.4%

Inactive Ingredient

Ammonium Acryloyldimethyltaurate/VP Copolymer, Argania Spinosa Kernel Oil, Bisabolol, Butyrospermum Parkii (Shea Butter) Extract, C12-15 Alkyl Benzoate, C12-20 Glucoside, C14-22 Alcohol, Caprylyl/Capryl Glucoside, Cetearyl Alcohol, Coco Glucoside, Dimethicone, Ethyl Ferulate, Ethylhexylglycerin, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate, Phenoxyethanol, Phospholipids, Polyester-5, Propylene Glycol, Sodium Acryloyl Dimethyl Taurate Copolymer, Sorbitan Oleate Decylglucoside Crosspolymer, Squalane, Tocopheryl Acetate, Triethoxycaprylylsi-lane, Urea, Water

Indications & Usage Section

High protection against sunburn

Otc Keep Out of Reach of Children

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


Structured Label Content

Warnings and Precautions (34071-1)

- 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 a doctor if rash occurs

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

Dosage and Administration (34068-7)

- Apply generously 15 minutes before sun exposure

- Reapply every 2 hours

- Use a water-resistant sunscreen if swimming or sweating

Section 51945-4 (51945-4)

Otc Purpose (OTC-Purpose)

Sunscreen

Otc Stop Use (OTC-Stop Use)

Stop use if rash occurs

Otc Questions (OTC-Questions)

+1) 866-322-3010

Otc Ask Doctor (OTC-Ask Doctor)



Ask a doctor if rash occurs

Otc Do Not Use (OTC-Do Not Use)

Do not use on damaged or broken skin

Otc When Using (OTC-When using)

When using this product keep out of eyes

Rinse with water to remove

Active Ingredient

Zinc Oxide 9.4%

Inactive Ingredient

Ammonium Acryloyldimethyltaurate/VP Copolymer, Argania Spinosa Kernel Oil, Bisabolol, Butyrospermum Parkii (Shea Butter) Extract, C12-15 Alkyl Benzoate, C12-20 Glucoside, C14-22 Alcohol, Caprylyl/Capryl Glucoside, Cetearyl Alcohol, Coco Glucoside, Dimethicone, Ethyl Ferulate, Ethylhexylglycerin, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate, Phenoxyethanol, Phospholipids, Polyester-5, Propylene Glycol, Sodium Acryloyl Dimethyl Taurate Copolymer, Sorbitan Oleate Decylglucoside Crosspolymer, Squalane, Tocopheryl Acetate, Triethoxycaprylylsi-lane, Urea, Water

Indications & Usage Section

High protection against sunburn

Otc Keep Out of Reach of Children (OTC-Keep Out of Reach of Children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)