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.
MOISTURIZER
- Manufacturer
- OXYGEN DEVELOPMENT, LLC
- Effective date
- 2021-02-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:38:26
Label at a glance#
ProductMOISTURIZER
Active ingredientOCTISALATE, AVOBENZONE, OXYBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure9 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months:Ask a doctor. Apply to all skin exposed to the sun. 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 a...
Storage and handling
Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: Awake Beauty c/o Reprot Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
Label contents#
Full prescribing information#
Active Ingredients
Homosalate 10.00%, Oxybenzone 5.00%, Octisalate 5.00%, Avobenzone 3.00%, Octocrylene 1.00%.
Purpose
Sunscreen
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.
Stop use
Stop use and ask doctor if rash occurs.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months:Ask a doctor.
- Apply to all skin exposed to the sun.
- 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:
-Limit time in the sun, especially from 10 a.m. - 2p.m.
-Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
- Protect the product in this container from excessive heat and direct sunlight.
- You may report a serious adverse reaction to: Awake Beauty c/o Reprot Reaction, LLC, P.O. Box 22, Plainsboro, New Jersey 08536-0222.
Inactive Ingredients
Water, Glyceryl Stearate, Glycerin, Propanediol, Cetearyl Alcohol, Squalane, Stearic Acid,
C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Polyester-8, Polysorbate 60, Potassium Cetyl Phosphate, Helianthus Annuus (Sunflower) Seed Oil/Helianthus Annuus Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Phenoxyethanol, Sclerotium Gum, Phenylethyl Resorcinol, Tribehenin, Dimethiconol, Caprylyl Glycol, Chlorphenesin, Allantoin, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Ceramide NG, PEG-10 Phytosterol, Sodium PCA, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Oligopeptide-68, Sodium Oleate, Linalool, Citral, Sodium Carbonate, Limonene, Citronellol, Geraniol, Tocopherol, Palmitoyl Hexapeptide-12, Farnesol, Mica, Titanium Dioxide, Iron Oxides.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
10ml, 61354-050-02
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-050-01 | 2023-01-30 | C162847 | 48780-1 | f386c649-ad0b-0266-e053-dadaa90a7c1a | AWAKE HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN |
| 61354-050-02 | 2023-01-30 | C162847 | 48780-1 | f386c649-ad0b-0266-e053-dadaa90a7c1a | AWAKE HELLO, SUNSHINE MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-050-01 | MOISTURIZER | 50 mg in 1 BOTTLE, GLASS | CREAM | 50 | 1 | |
| 61354-050-02 | MOISTURIZER | 10 mg in 1 BOTTLE, GLASS | CREAM | 10 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- MOISTURIZER
- AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
- WATER
- DIMETHICONE
- POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)
- PHENOXYETHANOL
- OCTISALATE
- STEARIC ACID
- BUTYLENE GLYCOL
- AVOBENZONE
- OXYBENZONE
- OCTOCRYLENE
- SQUALANE
- PHENYLETHYL RESORCINOL
- GLYCERYL MONOSTEARATE
- GLYCERIN
- ALKYL (C12-15) BENZOATE
- POTASSIUM CETYL PHOSPHATE
- HOMOSALATE
- PROPANEDIOL
- CETOSTEARYL ALCOHOL
- POLYSORBATE 60
- SUNFLOWER OIL
- BETASIZOFIRAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61354-050 | 61354-050-01, 61354-050-02 |
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 |
|---|---|---|---|---|---|---|
| bbed806c-117e-ffa2-e053-2a95a90a930a | bbed806c-117d-ffa2-e053-2a95a90a930a | 2021-02-22 | Warnings | bbed806c-117e-ffa2-e053-2a95a90a930a bbed806c-117d-ffa2-e053-2a95a90a930a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.