indie lee - daily spf primer spf 50 (81545-102)

indie lee - daily spf primer spf 50 (81545-102)
SPL v1
SPL
SPL Set ID eb070c0e-d7f1-f554-e053-2995a90a392b
Route
topical
Published
Effective Date 2022-10-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (12 g)
Inactive Ingredients
caprylyl glycol hydrogenated soybean lecithin caprylic/capric/lauric triglyceride hydrogenated jojoba oil/jojoba oil, randomized (iodine value 64-70) polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate propanediol tridecyl salicylate methylheptyl isostearate silicon dioxide nylon-12 methylpropanediol coco-caprylate niacinamide allantoin levomenol rice bran helianthus annuus whole tocopherol rosemary sodium chloride alkyl (c12-15) benzoate sodium hydroxide ferric oxide red ferrosoferric oxide tetrasodium glutamate diacetate lecithin, sunflower ferric oxide yellow phenylpropanol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2021-01-01
Purpose

SUNSCREEN

Description

ZINC OXIDE 12%

Medication Information

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 CONSULT A PHYSICIAN IF RASH OCCURS.

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

Directions
  • Apply liberally before sun exposure.
  • Reapply:
  • Use a water-resistant sunscreen if swimming or sweating
  • At least every 2 hours
  • 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 your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

Other Information

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Allantoin, Bisabolol, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Lecithin, Phenylpropanol, Tetrasodium Glutamate Diacetate, Hydrogenated Lecithin, Sodium Hydroxide, CI 77491, CI77492, CI 77499 (Iron Oxides)

Description

ZINC OXIDE 12%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 51945-4

Active Ingredient

ZINC OXIDE 12%

Questions Or Comments?

1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

Structured Label Content

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 CONSULT A PHYSICIAN IF RASH OCCURS.

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

Directions (DIRECTIONS)
  • Apply liberally before sun exposure.
  • Reapply:
  • Use a water-resistant sunscreen if swimming or sweating
  • At least every 2 hours
  • 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 your time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

Other Information (OTHER INFORMATION)

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Allantoin, Bisabolol, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Lecithin, Phenylpropanol, Tetrasodium Glutamate Diacetate, Hydrogenated Lecithin, Sodium Hydroxide, CI 77491, CI77492, CI 77499 (Iron Oxides)

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 12%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:27.935333 · Updated: 2026-03-14T23:00:54.830446