Indications and 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.
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
- Manufacturer
- MANA PRODUCTS,INC. | MANA PRODUCTS, INC
- Effective date
- 2024-08-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:16:51
Label at a glance#
ProductRETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 time in the sun especially from 10:...
Label contents#
Full prescribing information#
ACTIVE INGREDIENTS
Avobenzone 2%
Octinoxate 7.5%
Octisalate 5%
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.
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.
DIRECTIONS
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- Sun Protection Measures:
- Spending time in the sun increases risk of skin cancer and early 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 time in the sun especially from 10:00 a.m. - 2:00 p.m.
- wear long sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: ask a doctor.
OTHER INFORMATION
Protect the product in this container from excessive heat and direct sun.
INACTIVE INGREDIENTS
Cyclopentasiloxane, Dimethicone Crosspolymer, Polysilicone-11, C12-15 Alkyl Benzoate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Laureth-12, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Salicylic Acid, Mica, Silica, Phenoxyethanol, Titanium Dioxide
INDICATIONS & USAGE SECTION
Stop use and ask a doctor if rash occurs.
RECENT MAJOR CHANGES SECTION
dosage & admin update
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
PACKAGE LABELS.PRINCIPLE DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59735-800-01 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 59735-800-02 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 1 in 1 BOX | CREAM | 1 | 3 | |
| 59735-800-03 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 59735-800-04 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 1 in 1 BOX | CREAM | 1 | 3 | |
| 59735-800-05 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 59735-800-06 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 1 in 1 BOX | CREAM | 1 | 3 | |
| 59735-800-07 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 28 g in 1 TUBE | CREAM | 28 | 3 | |
| 59735-800-08 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | 1 in 1 BOX | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- ALKYL (C12-15) BENZOATE
- AVOBENZONE
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- OCTINOXATE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
- OCTISALATE
- CYCLOMETHICONE
- PHENOXYETHANOL
- POLYGLYCERYL-4 ISOSTEARATE
- HEXYL LAURATE
- LAURETH-12
- VITAMIN A PALMITATE
- SALICYLIC ACID
- MICA
- SILICON DIOXIDE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59735-800 | 59735-800-01, 59735-800-02, 59735-800-03, 59735-800-04, 59735-800-05, 59735-800-06, 59735-800-07, 59735-800-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20 | PML NYC, LLC | 316d905f-232c-d8a2-e063-6394a90adbc9 | 2026-04-17 | Warnings | 59735-800 |
| 1eba6db2-fce0-a428-e063-6294a90ac5d4 | eab747ac-251a-a1e5-e053-2a95a90a5d84 | 2024-08-02 | Warnings | 1eba6db2-fce0-a428-e063-6294a90ac5d4 eab747ac-251a-a1e5-e053-2a95a90a5d84 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.