Indie Lee - Mineral Sunscreen Spf 30 (81545-101)

Indie Lee - Mineral Sunscreen Spf 30 (81545-101)
SPL v5
SPL
SPL Set ID cc37a6e8-3ce3-5eb4-e053-2995a90a217a
Route
TOPICAL
Published
Effective Date 2020-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Maritime Pine Pomegranate Seed Oil Aloe Vera Leaf Panthenol Xanthan Gum Phenylethyl Alcohol Pentylene Glycol Propanediol Lauroyl Lysine Medium-chain Triglycerides Sorbitan Olivate Water Sunflower Oil Glycerin Squalane Dicaprylyl Carbonate Cetearyl Olivate Diglycerin Shea Butter Ethyl Esters Sorbitan Sesquioleate Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-09-17

Description

ZINC OXIDE 20%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 20%

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.
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

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.

Directions

Shake before use.

  • Apply generously to skin 15 minutes before sun exposure.
  • During sun exposure, reapply: After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every two hours

Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor

Active Ingredient

ZINC OXIDE 20%

Other Information

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

Inactive Ingredients

Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine

Questions Or Comments?

INDIELEE.COM

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


Structured Label Content

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.
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)

Purpose (PURPOSE)

SUNSCREEN

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.

Directions (DIRECTIONS)

Shake before use.

  • Apply generously to skin 15 minutes before sun exposure.
  • During sun exposure, reapply: After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every two hours

Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor

Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 20%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine

Questions Or Comments? (QUESTIONS OR COMMENTS?)

INDIELEE.COM

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


Advanced Ingredient Data


Raw Label Data

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