90fbf555-106c-4131-b572-ead9bbb246e6

SPL v5
SPL
SPL Set ID 90fbf555-106c-4131-b572-ead9bbb246e6
Route
topical
Published
Effective Date 2025-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (3 g) zinc oxide (6.8 g)
Inactive Ingredients
water titanium dioxide triethoxycaprylylsilane polyhydroxystearic acid (2300 mw) hydroxypropylcocoate peg-8 dimethicone alkyl (c12-15) benzoate phenyl trimethicone dimethicone/vinyl dimethicone crosspolymer (soft particle) squalane di-ppg-3 myristyl ether adipate caprylyl trisiloxane dimethicone, unspecified peg-10 dimethicone (600 cst) disteardimonium hectorite boron nitride royal jelly propanediol sodium chloride rice bran rosemary helianthus annuus flowering top tocopherol panthenol .alpha.-tocopherol acetate biosaccharide gum-4 chondrus crispus carrageenan ferric oxide red ferric oxide yellow ferrosoferric oxide medium-chain triglycerides withania somnifera flower nelumbo nucifera flower c10-11 isoparaffin phenoxyethanol propylene carbonate ethylhexylglycerin laureth-3 laureth-25

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-01

Purpose

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Description

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen


Medication Information

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

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Directions

• shake well

• apply liberally and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• children under 6 months of age: 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:

     o limit time in the sun, especially from 10 a.m.-2 p.m.

     o wear long-sleeved shirts, pants, hats, and sunglasses

Other Information
  • protect this product from excessive heat and direct sun
Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Hydroxypropylcocoate PEG-8 Dimethicone, Petroleum Distillates, Phenyl Trimethicone, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Squalane, Caprylyl Methicone, C10-11 Isoalkane, Boron Nitride, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Phenoxyethanol, Dimethicone, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Carbonate, Polyhydroxystearic Acid, Oryza Sativa (Rice) Bran Extract, Tocopheryl Acetate, Panthenol, Royal Jelly Powder, Biosaccharide Gum-4, Smithsonite Extract, Ethylhexylglycerin, Withania Somnifera Extract, Laureth-3, Laureth-25, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Chondrus Crispus Extract, Nelumbo Nucifera Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491/CI 77492/CI 77499)

Description

Octinoxate 3% .................. Sunscreen Zinc Oxide 6.8% ................ Sunscreen

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1

Warings

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 Center right away.

Product Label

Active Ingredients           purpose

Octinoxate 3% .................. Sunscreen

Zinc Oxide 6.8% ................ Sunscreen


Structured Label Content

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
Directions

• shake well

• apply liberally and evenly 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water resistant sunscreen if swimming or sweating

• children under 6 months of age: 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:

     o limit time in the sun, especially from 10 a.m.-2 p.m.

     o wear long-sleeved shirts, pants, hats, and sunglasses

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Hydroxypropylcocoate PEG-8 Dimethicone, Petroleum Distillates, Phenyl Trimethicone, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Squalane, Caprylyl Methicone, C10-11 Isoalkane, Boron Nitride, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Phenoxyethanol, Dimethicone, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG-10 Dimethicone, Propylene Carbonate, Polyhydroxystearic Acid, Oryza Sativa (Rice) Bran Extract, Tocopheryl Acetate, Panthenol, Royal Jelly Powder, Biosaccharide Gum-4, Smithsonite Extract, Ethylhexylglycerin, Withania Somnifera Extract, Laureth-3, Laureth-25, Helianthus Annuus (Sunflower) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Chondrus Crispus Extract, Nelumbo Nucifera Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491/CI 77492/CI 77499)

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Section 50565-1 (50565-1)

Warings

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 Center right away.

Product Label (Product label)

Active Ingredients           purpose (Active ingredients           Purpose)

Octinoxate 3% .................. Sunscreen

Zinc Oxide 6.8% ................ Sunscreen


Advanced Ingredient Data


Raw Label Data

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