counter beauty daily sheer defense spf 25

counter beauty daily sheer defense spf 25
SPL v1
SPL
SPL Set ID 3a22d88b-cdb5-5656-e063-6294a90a5b77
Route
topical
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (14.96 g)
Inactive Ingredients
polyglyceryl-3 pentaricinoleate tocopherol water cetearyl alcohol arachidyl glucoside polyhydroxystearic acid (2300 mw) caprylic/capric triglyceride arachidyl alcohol isostearic acid coco-caprylate coconut alkanes cichorium intybus (chicory) root oligosaccharides xanthan gum coco-caprylate/caprate behenyl alcohol lecithin, soybean phytic acid glycerin pentylene glycol coco glucoside phenoxyethanol ethylhexylglycerin squalane helianthus annuus (sunflower) seed oil sodium hyaluronate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-01

Description

Zinc Oxide 14.96%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Zinc Oxide 14.96%

Indications and Usage
  • Helps prevent sunburn.
  • If used as directed with other sun protection measure ( see Directions), decreases the risk of skin cancer and early skin aging caused by sun.
Dosage and Administration
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resitant sunscreen if swimming or sweating.
  • Children under 6: 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 sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
Description

Zinc Oxide 14.96%

Section 50565-1

If swalowed, get medical help or contact Poison Control Center right away.

Section 50566-9

rash occurs.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 50570-1

On damaged or broken skin.

Section 51727-6

Water, Coco-Caprylate, Caprylic/Capric Triglyceride, Glycerin, Squalane, Pentylene Glycol, Cetearyl Alcohol, Coconut Alkanes, Arachidyl Alchohol, Coco-Glucoside, Phenoxyethanol, Behenyl Alcohol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Xanthan Gum, Tocopherol, Phytic Acid, Helianthus Annuus (Sunflower) Seed oil, Cichorium Intybus (Chicory) Root Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Sodium Hyaluronate.

Section 51945-4

Section 55105-1

Sunscreen

Section 60561-8
  • protect the product in this container from excessive heat and direct sun.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Zinc Oxide 14.96%

Indications and Usage (34067-9)
  • Helps prevent sunburn.
  • If used as directed with other sun protection measure ( see Directions), decreases the risk of skin cancer and early skin aging caused by sun.
Dosage and Administration (34068-7)
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resitant sunscreen if swimming or sweating.
  • Children under 6: 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 sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
Section 50565-1 (50565-1)

If swalowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

rash occurs.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

On damaged or broken skin.

Section 51727-6 (51727-6)

Water, Coco-Caprylate, Caprylic/Capric Triglyceride, Glycerin, Squalane, Pentylene Glycol, Cetearyl Alcohol, Coconut Alkanes, Arachidyl Alchohol, Coco-Glucoside, Phenoxyethanol, Behenyl Alcohol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Xanthan Gum, Tocopherol, Phytic Acid, Helianthus Annuus (Sunflower) Seed oil, Cichorium Intybus (Chicory) Root Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Sodium Hyaluronate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60561-8 (60561-8)
  • protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data


Raw Label Data

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