Sun Shades Mineral Spf 30+ Content Of Label

Sun Shades Mineral Spf 30+ Content Of Label
SPL v1
SPL
SPL Set ID 6b4d59e2-04f5-4a37-a8fd-062b1dca0794
Route
TOPICAL
Published
Effective Date 2011-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (9.225 g) Zinc (18.45 g)
Inactive Ingredients
Alpha-tocopherol Acetate Ascorbyl Palmitate Bixa Orellana Seed C12-15 Alkyl Benzoate Cetostearyl Alcohol Cetyl Alcohol Cetyl Ethylhexanoate Dicaprylyl Carbonate Dihexadecyl Phosphate Edetate Disodium Glycerin Isostearic Acid Kukui Nut Oil Levomenol Macadamia Oil Medium-chain Triglycerides Neopentyl Glycol Diheptanoate Pentylene Glycol Phenoxyethanol Phenyl Trimethicone Polyhydroxystearic Acid (2300 Mw) Potassium Cetyl Phosphate Potassium Sorbate Shea Butter Sodium Chloride Trolamine Water Xanthan Gum Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2009-05-01
Description

Active ingredient Octisalate 5%, Zinc oxide 10%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity in the water or sweating

Dosage and Administration

Directions

  • apply liberally and evenly to all exposed areas before sun exposure
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

Description

Active ingredient Octisalate 5%, Zinc oxide 10%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash or irritation develops and lasts

Section 50567-7

When using this product keep out of the eyes. Rinse with water to remove.

Section 51727-6

Inactive ingredients

aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

Section 51945-4
Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

Octisalate 5%, Zinc oxide 10%

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity in the water or sweating

Dosage and Administration (34068-7)

Directions

  • apply liberally and evenly to all exposed areas before sun exposure
  • reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours.
  • children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

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 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation develops and lasts

Section 50567-7 (50567-7)

When using this product keep out of the eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

Inactive ingredients

aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, caprylic/capric triglyceride, cera alba, cetearyl alcohol, ceteth-10 phosphate, cetyl alcohol, cetyl ethylhexanoate, dicaprylyl carbonate, dicetyl phosphate, disodium EDTA, disodium lauriminodipropionate tocopheryl phosphates, glycerin, hydrogenated palm glycerides, isoeicosane, isostearic acid, macadamia ternifolia seed oil, neopentyl glycol diheptanoate, parfum, pentylene glycol, phenoxyethanol, phenyl trimethicone, polyester-7, polyhydroxystearic acid, potassium cetyl phosphate, potassium sorbate, sodium chloride, sucrose distearate, tocopherol, triethanolamine, water, xanthan gum

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Octisalate 5%, Zinc oxide 10%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:13.379188 · Updated: 2026-03-14T22:52:36.393397