1accbe67-c722-4af7-8422-0559ac4a987a

SPL v6
SPL
SPL Set ID 1accbe67-c722-4af7-8422-0559ac4a987a
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

Warnings

For external use only

Do not useon 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.

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

Section 55105-1

Product Label

Active Ingredients            Purpose

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

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

Structured Label Content

Warnings

For external use only

Do not useon 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.

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)

Section 55105-1 (55105-1)

Product Label (Product label)

Active Ingredients            Purpose (Active ingredients            Purpose)

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.987777 · Updated: 2026-03-14T23:12:05.275634